Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0831-2020·Announced 2020-01-29

Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Cross-Reactivity

Siemens is recalling 3,627 ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate 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, but the hazard is a potential for inaccurate test results (elevated folate) rather than a direct physical injury or high-risk pathogen, fitting the Moderate category for minor labeling or low-risk contamination issues.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 3,627 units of the Siemens ADVIA Centaur Folate (500 Test Kit Reference) for in vitro diagnostic (IVD) use in serum or red blood cell folate testing. The recall is due to a potential cross-reactivity issue where the homocysteine assay may cause elevated results in the folate assay.

The affected product is identified by SMN 10331250, and the recall covers all lots. The distribution pattern is nationwide and includes foreign distribution to numerous countries, including Armenia, Austria, Bahrain, Belgium, Bosnia and Herzegovina, Czech Republic, Denmark, Egypt, France, Georgia, Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Jordan, Lithuania, Nepal, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sudan, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, and Vatican City.

Healthcare facilities and laboratories should stop using the affected test kits and contact Siemens Healthcare Diagnostics, Inc. for further instructions or a replacement. The FDA has classified this as a Class II recall.

The recalled product

Product: Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell SMN: 10331250
Manufacturer: Siemens Healthcare Diagnostics, Inc
Category: Medical Device — In Vitro Diagnostics
Hazard: inaccurate-results
Affected units: 3,627

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 lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Siemens Healthcare Diagnostics, Inc

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