Siemens Healthcare recalls 100-test SARS-CoV-2 antigen kits due to insufficient validation 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 100-test SARS-CoV-2 antigen kits because the data submitted for emergency use authorization wasn't enough to confirm they work safely for the intended purpose. This means the tests might not be reliable for detecting the virus.
The tests were not sufficiently validated for their intended use based on the emergency use authorization data. This could mean the tests might not detect the virus accurately, leading to false negatives or positives.
People who bought the Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit) with specific lot numbers and expiration dates are affected. Those using the tests for home testing are most at risk if the tests are not validated properly.
Check the lot number and expiration date on the kit. Affected kits have lot numbers 44989001 (expiring October 2021) or 60407003 (expiring November 2021).
Look for lot numbers 44989001 (expiring October 2021) or 60407003 (expiring November 2021) on the test kit.
The data provided in the Emergency Use Authorization submission was insufficient to determine that the assays were adequately validated for the intended use.
The recall record does not specify a remedy, so contact Siemens Healthcare directly for instructions.
The recall indicates the tests may not be reliable due to insufficient validation, so they should not be used until further instructions are received.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0195-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0195-2022 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.
