Siemens Healthcare recalls Atellica IM aTG test kits with specific lot numbers due to potential positive bias against WHO reference standards. Affected kits may give inaccurate results.
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 Healthcare is recalling Atellica IM aTG test kits with certain lot numbers because they may show positive results when they shouldn't, leading to inaccurate thyroid tests. This could cause incorrect health decisions if used without the recall fix.
The test kits may produce false positive results when compared to the WHO reference standard. This could lead to incorrect thyroid hormone assessments if used without the recall fix. The risk is specific to certain lot numbers and does not cause immediate harm.
Healthcare providers using Atellica IM aTG test kits with lot numbers ending in 317 or lower are most at risk. Patients relying on these tests for thyroid hormone levels may be affected if the kits are used incorrectly.
Check the lot number on the Atellica IM aTG test kit packaging. Kits with lot numbers ending in 317 or lower (e.g., 56683313, 70390317) are affected. The product is sold by Siemens Healthcare.
Look for the lot number on the Atellica IM aTG test kit packaging. Affected kits have lot numbers ending in 317 or lower.
The Atellica IM aTG test kits with specific lot numbers may show positive results when they shouldn't, leading to inaccurate thyroid hormone tests compared to the WHO reference standard.
Check the lot number on the packaging. If it ends in 317 or lower, contact Siemens Healthcare for guidance on next steps.
The risk is low; the test kits may give inaccurate results but do not cause immediate harm. Affected kits should be checked and handled according to the recall 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-1236-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1236-2019 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.
