ADVIA Centaur CA 19-9 test kit recalled for measurement bias in samples
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 diagnostic test kits due to positive measurement bias in some samples. The affected kits may report falsely elevated test results, particularly around the normal limit of 35 U/mL.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II medical device recall for a diagnostic test where measurement bias in certain sample ranges could lead to diagnostic errors. No patient illness or injury is reported in the source text, but the risk of clinical impact from false positive results meets the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur CA 19-9 test kits (lot numbers 55972535 and 55973535) used with Atellica CI and Atellica IM Analyzers. The test is an in vitro diagnostic used to measure CA 19-9, a tumor-associated antigen in blood serum.
The recalled test kits exhibit positive measurement bias—meaning they report results higher than actual values—in some patient samples, particularly around the upper normal limit of 35 U/mL. This bias is not uniform across all sample concentrations; it is less pronounced for samples yielding results above 110 U/mL. The measurement bias was most evident in samples from the Asia Pacific region.
The affected kits have been distributed worldwide with US nationwide distribution.
The recalled product
- Product
- ADVIA Centaur CA 19-9 (250 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: 10491244
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
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)00630414574028(10)55972535(17)20240914
- (01)00630414574028(10)55973535(17)20240914 Kit Lot: 55972535
- 55973535
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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