--- title: "Siemens Healthcare Diagnostics, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Siemens Healthcare Diagnostics, 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/siemens-healthcare-diagnostics-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Siemens Healthcare Diagnostics, Inc. recall records **130** reported ongoing 135 records in this archive. Latest source date Jul 13, 2026. 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 Jul 13, 2026 FDA device enforcement ### [Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL](https://isitonrecall.com/recall/fda-device-z-2975-2026-syva-emit-2000-quinidine-assay-ref-4q019ul-contents-1x28-ml-1x14ml/) Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy. [Official source for Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2975-2026%22) Jul 13, 2026 FDA device enforcement ### [Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL](https://isitonrecall.com/recall/fda-device-z-2976-2026-beckman-coulter-emit-2000-quinidine-assay-ref-osr4q229-contents-r1-2-x-23-ml-r2-2x13-ml/) Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of CA and the country of Italy. [Official source for Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2976-2026%22) Jul 6, 2026 FDA device enforcement ### [Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic](https://isitonrecall.com/recall/fda-device-z-2890-2026-atellica-ch-urine-albumin-ref-11537225-in-vitro-diagnostic/) Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN\_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c\_E) results; Increased rate of reaction cuvette QC... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Curacao, St. Eus, Czech Republic, ... [Official source for Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2890-2026%22) Jun 26, 2026 FDA device enforcement ### [Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL](https://isitonrecall.com/recall/fda-device-z-2880-2026-syva-emit-disopyramide-assay-enzyme-immunoassay-lidocaine-smn-10445370-catalog-no-6n319ul/) Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small v... Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA and VA. The country of Japan. [Official source for Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2880-2026%22) Jun 26, 2026 FDA device enforcement ### [Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL](https://isitonrecall.com/recall/fda-device-z-2881-2026-syva-emit-tox-serum-tricyclic-antidepressant-calibrator-controls-smn-10445390-catalog-no-7c219ul/) out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limite... Class III Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states CA, ID, IL, IN, MA, MS, NC, NM, NY, OH, OK, OR, PA, WA, and Northern Mariana Islands part of USA and the countries of Canada... [Official source for Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2881-2026%22) Jun 8, 2026 FDA device enforcement ### [Atellica CH Enzymatic Hemoglobin A1c (A1c\_E). Material Number: 11097536.](https://isitonrecall.com/recall/fda-device-z-2703-2026-atellica-ch-enzymatic-hemoglobin-a1c-a1c-e-material-number-11097536/) The potential for intermittent well-to-well bias on the A1c\_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bangladesh, Bolivia, Brazil, Bulgaria, Burkina¿Faso, Canada, Chile, China, Co... [Official source for Atellica CH Enzymatic Hemoglobin A1c (A1c\_E). Material Number: 11097536.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2703-2026%22) May 7, 2026 FDA device enforcement ### [Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay](https://isitonrecall.com/recall/fda-device-z-2398-2026-siemens-dimension-tacrolimus-flex-reagent-cartridge-tac-ref-df207-smn-10700795-enzyme-immunoassay/) A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Brazil, Croatia, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Pakistan, Poland, Saudi... [Official source for Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immuno...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2398-2026%22) Apr 2, 2026 FDA device enforcement ### [epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;](https://isitonrecall.com/recall/fda-device-z-2005-2026-epoc-bgem-bun-test-card-25-pk-for-the-epoc-blood-analysis-system-siemens-material-number-smn-1073651/) Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inapprop... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Italy, Spain, Austria, Portugal, Ireland, France, Romania, Canada, India, Philippines, Mexico. [Official source for epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2005-2026%22) Mar 18, 2026 FDA device enforcement ### [Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.](https://isitonrecall.com/recall/fda-device-z-1980-2026-dimension-creatinine-flex-reagent-cartridge-material-number-10872079/) Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample results using lot numbers GA6307 and BA700... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Brazil, Cambodia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, Egypt,... [Official source for Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1980-2026%22) Feb 23, 2026 FDA device enforcement ### [Atellica CH Enzymatic Hemoglobin A1c (A1c\_E); Siemens Material Number (SMN): 11097536;](https://isitonrecall.com/recall/fda-device-z-1657-2026-atellica-ch-enzymatic-hemoglobin-a1c-a1c-e-siemens-material-number-smn-11097536/) A potential for depressed results for Atellica CH A1c\_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c\_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imp... Class II Reported ongoing Distribution: Domestic: Nationwide Distribution International: Argentina, Australia, Bangladesh, Brazil, Bulgaria , Canada, Chile, China, Colombia, Croatia , Cura¿ao, St Eus, Czech Republic ,... [Official source for Atellica CH Enzymatic Hemoglobin A1c (A1c\_E); Siemens Material Number (SMN): 11097536;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1657-2026%22) Jan 20, 2026 FDA device enforcement ### [Atellica CH Urine Albumin (UAlb). Material Number: 11537225](https://isitonrecall.com/recall/fda-device-z-1484-2026-atellica-ch-urine-albumin-ualb-material-number-11537225/) Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, German... [Official source for Atellica CH Urine Albumin (UAlb). Material Number: 11537225](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1484-2026%22) Oct 6, 2025 FDA device enforcement ### [IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;](https://isitonrecall.com/recall/fda-device-z-0491-2026-immulite-2000-oak-mix-specific-allergen-siemens-material-number-smn-10386105-catalog-number-l2kun6/) The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, ... [Official source for IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number:...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0491-2026%22) Oct 6, 2025 FDA device enforcement ### [3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number...](https://isitonrecall.com/recall/fda-device-z-0492-2026-3gallergy-specific-ige-universal-kit-kit-component-3gallergy-specific-ige-adjustor-antibody-l2uns1-3/) The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, ... [Official source for 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0492-2026%22) Oct 6, 2025 FDA device enforcement ### [Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;](https://isitonrecall.com/recall/fda-device-z-0493-2026-food-panel-3-specific-allergen-siemens-material-number-smn-10385891-catalog-number-fp3l4/) The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly ... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the state of CA and the countries of Argentina, Australia, Austria, Belgium, Bosnia Herzeg. , Brazil, Canary Islands, Chile, Colombia, ... [Official source for Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0493-2026%22) Sep 22, 2025 FDA device enforcement ### [Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number: (1) L2KPP2, (2) L2KPP6;](https://isitonrecall.com/recall/fda-device-z-0366-2026-assay-immulite-2000-intact-pth-test-code-ipt-siemens-material-number-smn-1-10381441-2-10381442-catal/) The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi syste... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID, IN, LA, MD, NC, NJ, NY, PA, SC and the countries of Argentina, Australia, Bolivia, Bosnia Herzeg, Bra... [Official source for Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2)...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0366-2026%22) Aug 11, 2025 FDA device enforcement ### [Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.](https://isitonrecall.com/recall/fda-device-z-2542-2025-atellica-ch-urinary-cerebrospinal-fluid-protein-ucfp-material-number-11097543/) Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombi... [Official source for Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2542-2025%22) Jul 7, 2025 FDA device enforcement ### [epoc BGEM BUN Test Card (25pk). Material Number: 10736515.](https://isitonrecall.com/recall/fda-device-z-2272-2025-epoc-bgem-bun-test-card-25pk-material-number-10736515/) Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in some epoc test card lots. All other analytes are performing as intended. The observed average bias for sodium was -4.4 mmol/L. The maximum bias observed was -14 mmol/... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Bahrain, Bolivia, Brazil, Canada, Canary Islands, Chile, Croatia, Denmark, Ecuador, Estonia, Fran... [Official source for epoc BGEM BUN Test Card (25pk). Material Number: 10736515.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2272-2025%22) Jun 26, 2025 FDA device enforcement ### [RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.](https://isitonrecall.com/recall/fda-device-z-2230-2025-rapidpoint-500-systems-wash-waste-cartridge-4-pack-material-number-10329097/) Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and thei... Class II Reported ongoing Distribution: worldwide distribution - US Nationwide and the countries of Canada, Chile, Japan, Paraguay. [Official source for RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2230-2025%22) Jun 4, 2025 FDA device enforcement ### [ADVIA¿ 120/2120/2120i SETpoint Calibrator](https://isitonrecall.com/recall/fda-device-z-2086-2025-advia-120-2120-2120i-setpoint-calibrator/) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA. [Official source for ADVIA¿ 120/2120/2120i SETpoint Calibrator](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2086-2025%22) Jun 4, 2025 FDA device enforcement ### [ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)](https://isitonrecall.com/recall/fda-device-z-2087-2025-advia-120-2120-2120i-3-in-1-testpoint-control-abn1-control/) Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of AR, AU, BR, CA, CL, CN, CO, CR, HK, ID, IN, JP, KR, MX, MY, PE, PY, SA, SG, TH, TW, UY, VN, & ZA. [Official source for ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2087-2025%22) ## Reasons in these listed records - Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inad... - Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN\_c) results; Falsely depressed Atellica CH Enzymatic Hemoglobin A1c (A1c\_E) results; Increased rate of reaction cuvette QC failures and Delaye... - Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes and a 0.2% po... - out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall health risk to lab technicians due to this issue is low, as exposure is limited by small volumes a... These examples come from this result page and are not a ranking of every recall reason. ## Checking Siemens Healthcare Diagnostics, Inc. ### Is there a recall on siemens healthcare diagnostics, inc. right now? This archive contains 135 records, including 130 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 Siemens Healthcare Diagnostics, Inc.](https://isitonrecall.com/check/?q=Siemens%20Healthcare%20Diagnostics%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)