Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is related to potential diagnostic inaccuracy due to environmental factors rather than direct physical injury or contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur CA 19-9 Assay, an in vitro immunoassay used to measure the CA 19-9 tumor-associated antigen in human serum. The recall involves 250-test and 50-test kits distributed worldwide, including in the United States and numerous international locations.
The recall is issued because the operating range of the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F). A change in room temperature may increase or decrease assay results, depending on the specific assay and system used. This temperature sensitivity poses a risk of inaccurate diagnostic results for patients being monitored for cancers of the exocrine pancreas.
Healthcare facilities and laboratories should stop using the affected products and contact Siemens Healthcare Diagnostics for further instructions. The recall covers all lot codes for the specified product quantities.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Ce
- 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)
- All lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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