Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 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, and the hazard involves potential inaccuracy in test results due to environmental factors rather than direct physical injury or contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur BR Assay kits for CA 27.29. The affected products include 250 Test Kits, 50 Test Kits, and Reference Kits distributed in the United States and internationally.
The recall is due to the operating range of the ADVIA Centaur systems, which 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 issue could affect the accuracy of quantitative serial determination of cancer antigen CA 27.29 in human serum.
The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Users should contact Siemens Healthcare Diagnostics, Inc. for further instructions on handling the recalled kits.
The recalled product
- Product
- Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum…
- 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)
- 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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