Siemens recalls ADVIA Centaur aTG test kits with specific lot numbers due to potential positive bias in thyroid hormone testing compared to WHO standards.
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 certain ADVIA Centaur aTG test kits that may give false high results for thyroid hormones. This could lead to incorrect diagnoses if used without the proper calibration.
The test kits may show higher levels of thyroid hormones than actual levels when compared to WHO reference standards. This positive bias could cause false positive results in thyroid hormone tests.
Lab users who have the specific lot numbers listed in the recall notice may be affected. Those performing thyroid hormone tests with these kits are at risk of inaccurate results.
Check the lot number on the kit packaging. The affected kits have specific lot numbers ending with 316 or lower for the aTG kit and ending with 317 or lower for the Atellica IM aTG kit.
Look for the lot number on the test kit packaging to determine if it is affected.
The test kits may show higher levels of thyroid hormones than actual levels when compared to WHO reference standards, potentially causing false positive results.
Check the lot number on the kit packaging. If it is listed in the recall, contact Siemens Healthcare for instructions.
The recall is for potential inaccurate test results, not immediate safety risks. Using these kits could lead to incorrect diagnoses.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1233-2019 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.
