Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0508-2013·Announced 2012-12-19

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.

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 2/5 (Moderate).

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…
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-diagnostic
temperature-sensitivity

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.

See all 7 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

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