Medical device diagnostic test shows measurement bias in certain samples
Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.
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 recall of a diagnostic test with documented measurement bias that could affect clinical decision-making. Per the rubric, this is rated High because it is a risk-of-harm product where no illnesses or injuries have been reported.
Plain-English summary
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 diagnostic test kits (lot numbers 55974535 and 55975535) due to a measurement bias affecting test accuracy.
The recalled test kits show a positive bias in results, particularly for samples near the upper limit of normal at 35 U/mL. This bias is not consistent across all concentration ranges, becoming less pronounced for samples above 110 U/mL. The bias was most significant in samples from the Asia Pacific region.
The affected test kits were distributed nationwide and internationally for use with Atellica CI and Atellica IM Analyzers in measuring CA 19-9, a tumor-associated antigen used in clinical diagnostics. No patient illnesses or injuries related to this measurement bias have been reported.
The recalled product
- Product
- Atellica IM 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: 10995490
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Category
- Medical Device — Diagnostic Test
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 (2)
- UDI-DI: (01)00630414598178(10)55974535(17)20240914 Kit Lot: 55974535
- 55975535
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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