Siemens Atellica IM CA 19-9 Assay Recalled for Positive Bias
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 kits due to positive bias in some samples, particularly in the Asia Pacific population.
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: The recall is classified as FDA Class II and involves a diagnostic test where positive bias could lead to incorrect clinical decisions, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM CA 19-9 (250 Test) kits, which are used for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum. The recall affects kits with UDI-DI (01)00630414598161(10)55977535(17)20240914 and Kit Lot 55977535. The product was distributed worldwide and nationwide in the US.
The recall was initiated because some samples showed a positive bias around the CA 19-9 upper limit of normal of 35 U/mL compared to previous lots. This bias was most pronounced in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
Healthcare facilities and laboratories using this product should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Atellica IM 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:10995489
- 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 (1)
- UDI-DI: (01)00630414598161(10)55977535(17)20240914 Kit Lot: 55977535
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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