Siemens ADVIA Centaur Folate Test Kits Recalled for Potential Interference
Siemens is recalling ADVIA Centaur Folate test kits because homocysteine assays may cause elevated folate results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where the hazard is inaccurate results, and no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 10,928 kits of the Siemens ADVIA Centaur Folate (500 Test Kit) used for in vitro diagnostics of folate in serum or red blood cells. The recall affects all lots of the product.
The recall was initiated because the homocysteine assay may cause elevated results in the folate assay. This interference could lead to inaccurate test readings.
The affected products were distributed nationwide and in numerous foreign countries, including Armenia, Austria, Bahrain, Belgium, and others. Healthcare facilities and laboratories that use these kits should stop using them and contact Siemens for further instructions.
The recalled product
- Product
- Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 10,928
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.
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