Siemens ADVIA Centaur aTG Test Kits Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur aTG test kits due to positive bias in anti-thyroglobulin results compared to WHO standards.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a measurement bias rather than a direct physical injury or acute contamination, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 10,414 units of the Siemens ADVIA Centaur aTG (500 test kit), identified by Siemens Material Number 10492399. The recall affects specific kit lots with numbers ending in 316 or lower, including lots 68750302, 68751302, 83578304, 91382304, 4642306, 8116306, 19098308, 22635308, 33640310, 39133310, 55625312, 55626312, 56285312, 69206316, and 73001316.
The recall was initiated because the affected test kits exhibit positive bias in anti-thyroglobulin measurements when compared to the standardization to the World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use. This discrepancy may affect the accuracy of test results.
The affected kits were distributed nationwide and in various foreign locations. Users of these test kits should check their lot numbers against the list provided in the recall notice and contact Siemens Healthcare Diagnostics for further instructions or replacement.
The recalled product
- Product
- SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 10,414
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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