Siemens Atellica IM CA 19-9 Test Kit Recall: Measurement Bias in Samples
Siemens is recalling Atellica IM CA 19-9 test kits (Lot 56434535) due to positive bias in measurement of tumor marker levels in some samples, particularly from Asia Pacific regions.
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: FDA Class II diagnostic device with positive measurement bias affecting result accuracy. No patient illnesses or injuries reported. This constitutes a risk-of-harm product where injury has not yet been reported, satisfying the High classification criterion.
Plain-English summary
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 test kits (Kit Lot 56434535) used to quantitatively measure CA 19-9 tumor-associated antigen in patient blood samples. The test kits are designed for use with Atellica CI and Atellica IM analyzers.
The affected test kits exhibit a positive bias—reporting higher CA 19-9 levels than actual values—in some samples, particularly those near 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 the entire measuring range; it is less pronounced in samples with concentrations above 110 U/mL.
Healthcare providers and laboratory personnel using the Atellica analyzers with this lot number should contact Siemens Healthcare Diagnostics for guidance. The test kits were distributed nationwide in the US and worldwide.
The recalled product
- Product
- Atellica IM CA 19-9 (250 Test - REF)-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: 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 (1)
- UDI-DI: (01)00630414293516(10)56434535(17)20240914 Kit Lot: 56434535
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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