Diagnostic test shows measurement bias at critical threshold
Siemens Healthcare Diagnostics is recalling ADVIA Centaur CA 19-9 test kits due to positive bias in measurements around the critical threshold of 35 U/mL, affecting diagnostic accuracy.
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: This is an FDA Class II recall addressing a measurement inaccuracy (positive bias) in a diagnostic test. No illnesses or injuries have been reported. The issue is treated as a precautionary recall to prevent potential misinterpretation of patient results.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur CA 19-9 test kits (lot numbers 55970535 and 55971535) used to measure CA 19-9 tumor-associated antigen levels in patient blood samples. These in vitro diagnostic tests are used with Atellica CI and Atellica IM analyzers for quantitative measurement of CA 19-9.
The recalled test kits produce artificially elevated (positive bias) measurements for some samples, particularly around the upper limit of normal of 35 U/mL. The bias is most pronounced in samples from the Asia Pacific region and is not consistent across all measurement ranges—the effect is less pronounced for samples with results above 110 U/mL.
The affected test kits have been distributed nationwide in the United States and worldwide. Healthcare facilities using these specific lot numbers should review their testing practices and contact Siemens Healthcare Diagnostics for guidance on managing affected kits and assessing potential impact on prior patient results.
The recalled product
- Product
- ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum using the Atellica CI and Atellica IM Analyzers SMN: 10491379 SMN: 11206239
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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: (01)00630414574257(10)55970535(17)20240914
- (01)00630414574257(10)55971535(17)20240914 Kit Lot: 55970535
- 55971535
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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