--- title: "Abbott Molecular, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Abbott Molecular, Inc. 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-molecular-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Abbott Molecular, Inc. recall records **20** reported ongoing 24 records in this archive. Latest source date Apr 28, 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 Apr 28, 2025 FDA device enforcement ### [Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the...](https://isitonrecall.com/recall/fda-device-z-1748-2025-alinity-m-resp-4-plex-amplification-amp-kit-ce-list-number-09n79-090-a-multiplex-real-time-reverse-t/) There were reports of an increase in reactive negative controls and false positive results. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1748-2025%22) Apr 28, 2025 FDA device enforcement ### [Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualita...](https://isitonrecall.com/recall/fda-device-z-1749-2025-alinity-m-resp-4-plex-amp-kit-list-number-09n79-096-a-multiplex-real-time-reverse-transcription-rt-p/) There were reports of an increase in reactive negative controls and false positive results. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1749-2025%22) Mar 20, 2025 FDA device enforcement ### [The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).](https://isitonrecall.com/recall/fda-device-z-1665-2025-the-alinity-m-system-is-designed-to-automate-the-steps-for-nucleic-acid-testing-model-numbers-includ/) The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution. [Official source for The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers in...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1665-2025%22) Sep 12, 2024 FDA device enforcement ### [Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091](https://isitonrecall.com/recall/fda-device-z-0233-2025-abbott-alinity-m-hpv-amp-kit-used-with-the-alinity-m-system-product-codes-a-ref-09n15-095-b-ref-09n1/) Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching ... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) c... [Official source for Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0233-2025%22) Sep 12, 2024 FDA device enforcement ### [Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;](https://isitonrecall.com/recall/fda-device-z-0234-2025-abbott-alinity-m-sti-amp-kit-used-with-the-alinity-m-system-product-codes-a-ref-09n17-095-b-ref-09n1/) Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching ... Class II Reported ongoing Distribution: Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, DC, FL, GA, IN, IL, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OR, PA, SC, TN, TX, VA, WA, and WI; and foreign (OUS) c... [Official source for Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0234-2025%22) Mar 20, 2024 FDA device enforcement ### [Alinity m System, Part Number: 08N53-002](https://isitonrecall.com/recall/fda-device-z-1602-2024-alinity-m-system-part-number-08n53-002/) The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an iss... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CAMEROON, CANADA... [Official source for Alinity m System, Part Number: 08N53-002](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1602-2024%22) Feb 1, 2024 FDA device enforcement ### [In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;](https://isitonrecall.com/recall/fda-device-z-1188-2024-in-vitro-diagnostic-kits-1-abbott-vysis-mdm2-cep-12-fish-probe-kit-ref-01n15-010-2-abbott-vysis-lsi/) Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. Class III Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA. [Official source for In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbot...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1188-2024%22) Feb 1, 2024 FDA device enforcement ### [In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis Tel...](https://isitonrecall.com/recall/fda-device-z-1189-2024-in-vitro-diagnostic-kits-1-abbott-vysis-lsi-atm-11q22-3-spectrmorange-probe-ref-01n33-020-2-abbott-v/) Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. Class III Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA. [Official source for In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1189-2024%22) Feb 1, 2024 FDA device enforcement ### [Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28\* (\*This part number is a spare to the M2000sp.)](https://isitonrecall.com/recall/fda-device-z-1190-2024-wash-station-m1000-wash-station-assembly-diti-slide-ref-04j72-28-this-part-number-is-a-spare-to-the/) Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. Class III Reported ongoing Distribution: US Nationwide distribution in the states of AL, CA, IL, MA, MD, MN, NY, and PA. [Official source for Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28\* (\*This part number is a spa...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1190-2024%22) Oct 30, 2023 FDA device enforcement ### [Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay f...](https://isitonrecall.com/recall/fda-device-z-0407-2024-alinity-m-hcv-amp-kit-list-ref-numbers-a-08n50-095-and-b-08n50-090-the-alinity-m-hcv-assay-is-an-in/) Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. Class II Reported ongoing Distribution: Worldwide [Official source for Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0407-2024%22) Dec 9, 2022 FDA device enforcement ### [Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.](https://isitonrecall.com/recall/fda-device-z-1009-2023-alinity-m-system-the-alinity-m-system-is-designed-to-automate-the-steps-for-nucleic-acid-testing-whi/) The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconf... Class II Reported ongoing Distribution: x [Official source for Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1009-2023%22) Nov 22, 2022 FDA device enforcement ### [Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096](https://isitonrecall.com/recall/fda-device-z-0739-2023-abbott-alinity-m-resp-4-plex-amp-kit-part-number-09n79-096/) Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. Class II Reported ongoing Distribution: Worldwide [Official source for Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0739-2023%22) Nov 22, 2022 FDA device enforcement ### [Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090](https://isitonrecall.com/recall/fda-device-z-0740-2023-abbott-alinity-m-resp-4-plex-amp-kit-part-number-09n79-090/) Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. Class II Reported ongoing Distribution: Worldwide [Official source for Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0740-2023%22) Nov 11, 2022 FDA device enforcement ### [Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.](https://isitonrecall.com/recall/fda-device-z-1349-2023-abbott-alinity-m-system-ref-08n53-002-containing-amplification-detetction-unit-adu-4/) The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of r... Class II Reported ongoing Distribution: US Distribution to state of: PA, a government account. [Official source for Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1349-2023%22) Oct 12, 2022 FDA device enforcement ### [Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use](https://isitonrecall.com/recall/fda-device-z-0268-2023-alinity-m-system-ref-08n53-002-for-in-vitro-diagnostic-use/) Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was found that the software... Class II Reported ongoing Distribution: Worldwide distribution. [Official source for Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0268-2023%22) Aug 19, 2022 FDA device enforcement ### [Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.](https://isitonrecall.com/recall/fda-device-z-1679-2022-abbott-alinity-m-sars-cov-2-ctrl-kit-ref-09n78-085-each-kit-contains-12-x-1-3ml-ctrl-and-12-x-1-3-ml/) Reports received of an increase of message code 9186 (internal control failed) when using the kit. Class II Reported ongoing Distribution: Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military di... [Official source for Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1679-2022%22) Jul 19, 2022 FDA device enforcement ### [The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.](https://isitonrecall.com/recall/fda-device-z-1518-2022-the-alinity-m-system-ref-08n53-002-for-in-vitro-diagnostic-use/) Incorrect optical calibration Class II Reported completed Distribution: There was only foreign distribution to Italy. [Official source for The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1518-2022%22) Mar 4, 2022 FDA device enforcement ### [Alinity m HBV Application Specification File (US and CE)](https://isitonrecall.com/recall/fda-device-z-0883-2022-alinity-m-hbv-application-specification-file-us-and-ce/) There is a potential for misquantitation high results of negative samples. Class II Reported ongoing Distribution: US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, E... [Official source for Alinity m HBV Application Specification File (US and CE)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0883-2022%22) Mar 4, 2022 FDA device enforcement ### [Alinity m HBV AMP Kit (US and CE)](https://isitonrecall.com/recall/fda-device-z-0884-2022-alinity-m-hbv-amp-kit-us-and-ce/) There is a potential for misquantitation high results for negative samples. Class II Reported ongoing Distribution: US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, E... [Official source for Alinity m HBV AMP Kit (US and CE)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0884-2022%22) Feb 11, 2022 FDA device enforcement ### [Alinity m Integrated Reaction Units (IRU)](https://isitonrecall.com/recall/fda-device-z-0710-2022-alinity-m-integrated-reaction-units-iru/) There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. Class II Reported terminated Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI. [Official source for Alinity m Integrated Reaction Units (IRU)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0710-2022%22) ## Reasons in these listed records - There were reports of an increase in reactive negative controls and false positive results. - The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user. - Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m L... - The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the us... These examples come from this result page and are not a ranking of every recall reason. ## Checking Abbott Molecular, Inc. ### Is there a recall on abbott molecular, inc. right now? This archive contains 24 records, including 20 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 Molecular, Inc.](https://isitonrecall.com/check/?q=Abbott%20Molecular%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)