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.
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.
The recall is based on insufficient data from the Emergency Use Authorization submission to confirm the test kits work correctly for their intended purpose. This could result in false negative results, meaning the virus might be present but not detected.
Healthcare facilities and labs using the Centaur SARS-CoV-2 Antigen Test Kits with specific lot numbers and expiration dates are affected. Individuals using these kits for home testing are at minimal risk if they follow standard procedures.
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.
Reach out to Siemens Healthcare for specific instructions on how to handle the recalled test kits.
The data provided in the Emergency Use Authorization submission was insufficient to determine that the assays were adequately validated for the intended use.
Lot numbers 44990001 (expiring October 2021) and 60408003 (expiring November 2021).
The recall does not require immediate stop use; contact Siemens Healthcare for specific instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0196-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0196-2022 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
