Siemens recalls Atellica IM aTG (100 test kit) with specific lot numbers due to potential positive bias against WHO reference standards, which may affect test accuracy.
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
Siemens is recalling Atellica IM aTG (100 test kit) with certain lot numbers because these kits may show false positive results when compared to WHO reference standards. This could lead to inaccurate thyroid hormone tests if used without correction.
The recalled kits may show positive bias when compared to the WHO reference standard, meaning they could indicate higher thyroid hormone levels than actually present. This could lead to false positive results in thyroid tests if not corrected for.
Users of the Atellica IM aTG test kit with lot numbers ending in 317 or lower are affected. Laboratory staff and healthcare providers who perform thyroid tests are most at risk of inaccurate results.
Check the lot number on the kit packaging. Recalled kits have lot numbers ending in 317 or lower, such as 72259303, 87903305, and others listed in the recall notice.
Look for the lot number on the kit packaging; recalled kits have numbers ending in 317 or lower.
The recalled kits may show positive bias when compared to the WHO reference standard, potentially leading to inaccurate thyroid hormone test results.
Kits with lot numbers ending in 317 or lower, such as 72259303, 87903305, and others listed in the recall notice.
No, the recall does not require stopping use; users should check the lot number and contact Siemens if needed.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1235-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1235-2019 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.
