ADVIA Centaur aTPO Assay kits recalled due to positive result bias
Siemens Healthcare is recalling 5,622 ADVIA Centaur aTPO Assay kits due to test accuracy issues. The affected lots produce results that are biased higher at and below the 60 U/mL threshold.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a diagnostic assay with documented accuracy issues that could affect patient care. While no illnesses or injuries are currently reported, the risk-of-harm from biased diagnostic results meets the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 5,622 ADVIA Centaur aTPO Assay kits (Material Numbers 10630886 and 10630887) because of positive bias in patient results. The affected lots (26053337, 26054337, 26051337, 26052337) produce results that are biased higher at and below the 60 U/mL cutoff when compared to alternate lots on the Atellica IM analyzer.
The aTPO assay is used to measure thyroid antibodies in patient serum. When test results are biased higher than accurate, users may receive incorrect information about a patient's antibody levels, which could affect clinical decisions.
The affected kits were distributed worldwide, including throughout the United States.
The recalled product
- Product
- ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- positive-bias
- diagnostic-inaccuracy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: Material Number 10630886 (100 Test) - 00630414587837
- Material Number 10630887 (500 Test) - 00630414587844
- Lot Number: 26053337 26054337 26051337 26052337
Distribution
Distributed nationwide across the United States.
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