Siemens recalls ADVIA Centaur aTG (500 test kit) lots ending in 316 or lower due to positive bias against WHO reference standards. Affected kits may give inaccurate thyroid hormone 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 is recalling certain ADVIA Centaur aTG (500 test kit) models because they may give falsely high thyroid hormone results compared to WHO standards. This could lead to incorrect diagnoses if used for thyroid tests.
The test kits may show higher thyroid hormone levels than actual levels when compared to WHO reference standards. This positive bias could cause false high readings, potentially leading to incorrect diagnoses or treatment decisions.
People who use the ADVIA Centaur aTG (500 test kit) for thyroid hormone testing. Those with thyroid conditions or regular lab tests are most at risk of inaccurate results.
Check the lot number on the kit packaging. Kits with lot numbers ending in 316 or lower (e.g., 68750302, 83578304) are affected. These kits were sold between December 2018 and June 2019.
Look for the lot number on the kit packaging; affected kits end in 316 or lower.
The test kits may show higher thyroid hormone levels than actual levels when compared to WHO reference standards, potentially causing false high readings.
The recall record does not specify a remedy or action for affected kits.
The recall indicates a potential for inaccurate thyroid hormone results, which could lead to incorrect diagnoses. However, no specific health risks are mentioned.
We’ve drafted a message you can send Siemens to request your refund or repair — edit it as you like.
Subject: Recall Z-1234-2019 — Siemens Siemens Hello, I own a Siemens that is covered by recall Z-1234-2019 from Siemens. 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.
