Lower riskMedical device recall · FDA · Published September 22, 2021
Siemens Healthcare Centaur SARS-CoV-2 Antigen Test Kits: Insufficient Validation Data
Siemens Healthcare recalls Centaur SARS-CoV-2 Antigen Test Kits (100 tests) due to insufficient validation data in EUA submission. Affected kits have specific lot numbers and expiration dates. Consumers should contact Siemens for details.
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
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Contact the company
📍Recalling firmSiemens Healthcare Diagnostics, Inc333 Coney St · East Walpole, MA 02032-1516
✎ GovInfoNow plain-language explainer
Siemens Healthcare is recalling Centaur SARS-CoV-2 Antigen Test Kits (100 tests) because the data submitted for emergency use authorization wasn't enough to confirm the tests work as intended. This means the kits might not detect the virus reliably, which could lead to false negatives. Read more at govinfonow.com/recall/61762-siemens-healthcare-centaur-sars-cov-2-antigen-test-kits-insufficient.
“Siemens Healthcare Centaur SARS-CoV-2 Antigen Test Kits: Insufficient Validation Data.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61762-siemens-healthcare-centaur-sars-cov-2-antigen-test-kits-insufficient. Based on FDA recall #Z-0196-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0196-2022%22&limit=1).
The FDA announced on Sept. 22, 2021, that Siemens Healthcare Diagnostics recalled ADVIA Centaur SARS-CoV-2 Antigen Assay kits because insufficient data prevented validation for intended use. The agency classified the recall as Class II.
How to tell if you have it
Brand: Siemens Healthcare
Product: ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit)
SMN: 11207866
UPC: 00630414611747
Lot #44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007
Lot #60408003, Exp. Date 2021-11-12, UDI # (01)00630414611747(10)60408003(17)20211112
Quantity: 261 kits
Distribution: US Nationwide in AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI
The hazard
According to the FDA, data provided in the Emergency Use Authorization submission was insufficient to determine that the assays were adequately validated for their intended use.
Context
GovInfoNow's records show Siemens Healthcare Diagnostics has 150 other recalls on record since June 7, 2017. Recent brand recalls include the Aug. 17, 2026, Atellica CH RCRP Test recall for false high results and the July 13, 2026, Beckman Coulter Emit 2000 Quinidine Assay recall for incorrect patient treatment risk. Other recent recalls of similar products include the Dec. 15, 2025, Diagnostica Stago Asserachrom HPIA Kit recall and the July 24, 2026, Biomerieux VITEK 2 AST-N461 Test Kit recall.
How to tell if you have this one
Check for lot numbers 44990001 (expiring October 2021) or 60408003 (expiring November 2021) on the test kit packaging. The kits have a specific UDI code format that includes these lot numbers and expiration dates.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.
Recall number
Product, codes & lots
Quantity
Z-0195-2022
Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861; Lot # 44989001 - Exp. Date 2021-10-07, UDI # (01)00630414611846(10)44989001(17)20211007; Lot # 60407003 - Exp. Date 2021-03-22, UDI # (01)00630414611846(10)60407003(17)20211112.
149 kits
Z-0196-2022
ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866; Lot # 44990001, Exp. Date 2021-10-07, UDI # (01)00630414611747(10)44990001(17)20211007. Lot # 60408003, Exp. Date 2021-11-12, UDI # (01)00630414611747(10)60408003(17)20211112.
261 kits
Based on the official FDA remedy
What to do — step by step
Contact Siemens Healthcare
Reach out to Siemens Healthcare for specific instructions on how to handle the recalled test kits.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC, NV, NY, OR, PA, PR, VA and VI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Colorado, District of Columbia, Georgia, Illinois, Maine, Nevada, New York, North Carolina, Oregon, Pennsylvania, Puerto Rico, Virginia.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0196-2022 (September 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0196-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.