--- title: "Abbott Laboratories Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Abbott Laboratories recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/abbott-laboratories/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Abbott Laboratories recall records **61** reported ongoing 79 records in this archive. Latest source date Nov 13, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Nov 13, 2025 FDA device enforcement ### [Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20](https://isitonrecall.com/recall/fda-device-z-0961-2026-alinity-ci-series-system-control-module-scm-ref-03r70-01-03r70-20/) Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lowe... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ,... [Official source for Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0961-2026%22) Sep 18, 2025 FDA device enforcement ### [Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Descri...](https://isitonrecall.com/recall/fda-device-z-0489-2026-brand-name-alinity-hq-analyzer-product-name-alinity-hq-analyzer-model-catalog-number-09p68-01-softwa/) Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN, NC, NY, OK and OUS (foreign) to countries of: ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, B... [Official source for Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0489-2026%22) Mar 18, 2025 FDA device enforcement ### [Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No](https://isitonrecall.com/recall/fda-device-z-1652-2025-brand-name-cell-dyn-ruby-product-name-cell-dyn-ruby-model-catalog-number-08h67-01-software-version-a/) When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Man... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, ... [Official source for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1652-2025%22) Mar 18, 2025 FDA device enforcement ### [Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No](https://isitonrecall.com/recall/fda-device-z-1653-2025-brand-name-cell-dyn-ruby-product-name-cell-dyn-ruby-model-catalog-number-08h67-03-software-version-a/) When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Man... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, ... [Official source for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-03 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1653-2025%22) Mar 18, 2025 FDA device enforcement ### [Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No](https://isitonrecall.com/recall/fda-device-z-1654-2025-brand-name-cell-dyn-ruby-product-name-cell-dyn-ruby-model-catalog-number-08h67-10-software-version-a/) When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Man... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, ... [Official source for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1654-2025%22) Mar 18, 2025 FDA device enforcement ### [Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No](https://isitonrecall.com/recall/fda-device-z-1655-2025-brand-name-cell-dyn-ruby-product-name-cell-dyn-ruby-model-catalog-number-08h67-13-software-version-a/) When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Man... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, ... [Official source for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-13 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1655-2025%22) Mar 18, 2025 FDA device enforcement ### [Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Version: All software versions Product Description: CELL-DYN Ruby](https://isitonrecall.com/recall/fda-device-z-1656-2025-brand-name-cell-dyn-ruby-product-name-cell-dyn-ruby-model-catalog-number-04u42-84-software-version-a/) When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Man... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to the following states: AR, AZ, CA, CO, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, ND, NE, NJ, NV, NY, OH, OK, PA, PR, SC, TN, TX, ... [Official source for Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 04U42-84 Software Ver...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1656-2025%22) Jun 14, 2024 FDA device enforcement ### [Alinity hq Analyzer, REF: 09P68-01](https://isitonrecall.com/recall/fda-device-z-2681-2024-alinity-hq-analyzer-ref-09p68-01/) 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MC... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of NY, OK, NC and the countries of ALBANIA, ARGENTINA, AUSTRALIA, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVINA, Botswana, BRA... [Official source for Alinity hq Analyzer, REF: 09P68-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2681-2024%22) Feb 21, 2024 FDA device enforcement ### [ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.](https://isitonrecall.com/recall/fda-device-z-1476-2024-architect-stat-myoglobin-reagent-kit-ln-2k43-25-and-2k43-20/) The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis of myocardial infarction. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IL, KS, LA, MI, MO, MS, NE, NY, OH, OR, PA, TX, VA, and WI. The countries of Angola, Austria, Bel... [Official source for ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1476-2024%22) Oct 31, 2023 FDA food enforcement ### [Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.](https://isitonrecall.com/recall/fda-food-f-0328-2024-similac-probiotic-tri-blend-0-017oz-0-50g-packaged-in-foil-packets-50-foil-packets-per-carton-3-cart/) Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive Class II Reported terminated Distribution: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, M... [Official source for Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carto...](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0328-2024%22) Oct 19, 2023 FDA device enforcement ### [Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-parameter, automated hematology analyzer.](https://isitonrecall.com/recall/fda-device-z-0604-2024-abbott-cell-dyn-ruby-model-cd-ruby-list-number-08h67-01-and-abbott-cell-dyn-sapphire-model-cd-sapphi/) The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class II Reported ongoing Distribution: Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, ... [Official source for Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0604-2024%22) Oct 19, 2023 FDA device enforcement ### [Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and...](https://isitonrecall.com/recall/fda-device-z-0680-2024-alinity-i-processing-module-ref-03r65-01-the-alinity-i-processing-module-is-a-fully-automated-immuno/) The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class II Reported ongoing Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN... [Official source for Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated imm...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0680-2024%22) Oct 19, 2023 FDA device enforcement ### [Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and a...](https://isitonrecall.com/recall/fda-device-z-0681-2024-alinity-c-processing-module-ref-03r67-01-the-alinity-c-processing-module-is-a-fully-automated-chemis/) The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class II Reported ongoing Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN... [Official source for Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated che...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0681-2024%22) Oct 19, 2023 FDA device enforcement ### [ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests...](https://isitonrecall.com/recall/fda-device-z-0682-2024-architect-c4000-processing-module-ref-02p24-01-02p24-02-02p24-40-01r24-56-01r25-56-the-abbott-archit/) The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex). Class II Reported ongoing Distribution: U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN... [Official source for ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott AR...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0682-2024%22) May 30, 2023 FDA device enforcement ### [Alinity ci-series System Control Module, REF: 03R70-01](https://isitonrecall.com/recall/fda-device-z-0613-2024-alinity-ci-series-system-control-module-ref-03r70-01/) There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user ... Class II Reported ongoing Distribution: US: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, W... [Official source for Alinity ci-series System Control Module, REF: 03R70-01](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0613-2024%22) Mar 28, 2023 FDA food enforcement ### [Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton](https://isitonrecall.com/recall/fda-food-f-0698-2023-zone-perfect-fudge-graham-bar-50g-bars-packaged-in-foil-wrapped-12-bars-individually-wrapped-per-car/) Potential of foreign material (hard plastic) within product Class II Reported terminated Distribution: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV [Official source for Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per...](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0698-2023%22) Nov 24, 2022 FDA device enforcement ### [Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels](https://isitonrecall.com/recall/fda-device-z-0958-2023-alinity-reaction-vessels-ref-06p1401-for-use-with-alinity-i-systems-architect-reaction-vessels/) Reaction vessels may contain a potential contaminant that could affect their optical performance. Class III Reported ongoing Distribution: US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV [Official source for Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0958-2023%22) Oct 13, 2022 FDA food enforcement ### [Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case](https://isitonrecall.com/recall/fda-food-f-0154-2023-pedialyte-unflavored-electrolyte-solution-2-fl-oz-plastic-reclosable-bottle-12-4-packs-in-a-case/) Compromised seal integrity which could lead to spoilage Class II Reported terminated Distribution: Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachus... [Official source for Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0154-2023%22) Oct 13, 2022 FDA food enforcement ### [Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case](https://isitonrecall.com/recall/fda-food-f-0155-2023-pedialyte-unflavored-export-to-canada-2-fl-oz-plastic-reclosable-bottle-48-count-case/) Compromised seal integrity which could lead to spoilage Class II Reported terminated Distribution: Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachus... [Official source for Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0155-2023%22) Oct 13, 2022 FDA food enforcement ### [Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case](https://isitonrecall.com/recall/fda-food-f-0156-2023-similac-360-total-care-2-fl-oz-reclose-able-plastic-bottle-packaged-as-6-count-carton-12-count-carto/) Compromised seal integrity which could lead to spoilage Class II Reported terminated Distribution: Domestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachus... [Official source for Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count ...](https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0156-2023%22) ## Reasons in these listed records - Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to... - Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. - When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual. - 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low h... These examples come from this result page and are not a ranking of every recall reason. ## Checking Abbott Laboratories ### Is there a recall on abbott laboratories right now? This archive contains 79 records, including 61 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Abbott Laboratories](https://isitonrecall.com/check/?q=Abbott%20Laboratories) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)