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, but the source text describes a standardization bias without reporting any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 10,673 units of the Siemens ADVIA Centaur aTG (100 test kit) (SMN: 10492398). The recall affects specific lots with expiration dates ranging from December 2018 to June 2019. The products were distributed nationwide and in numerous foreign countries.
The recall was initiated because the test kits exhibit positive bias in anti-thyroglobulin results 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.
Healthcare facilities and distributors should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. Consumers should not use these products for diagnostic purposes.
The recalled product
- Product
- Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 10,673
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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