Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Folate 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, and the hazard involves potential inaccuracies in diagnostic results due to temperature sensitivity, which fits the criteria for moderate severity without reported injuries or hospitalizations.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Folate (FOL) assays, including 100-test and 500-test kits and reference kits. The recall involves approximately 27,392 100-test kits, 21,045 500-test kits, and 3,773 reference kits. The products are intended for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems.
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 temperature sensitivity could lead to inaccurate diagnostic results.
The products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. All lot codes are affected. Users of these assays should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood…
- 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)
- Al 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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