Diagnostic folate test kits recalled for negative measurement bias
Siemens ADVIA Centaur Folate 100 test kits are recalled due to negative bias when whole blood calibration is used to test serum samples. The affected kits may produce falsely low 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: FDA Class II recall for diagnostic test with documented measurement bias that could result in missed or under-diagnosed folate deficiency. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no illnesses have been reported despite the potential for patient harm through diagnostic error.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Folate 100 test kits (Siemens Material Number 10310308), used to measure folate levels in human serum and red blood cells. Approximately 14,669 kits have been distributed nationwide and internationally.
The recall was triggered by negative bias that occurs when whole blood calibration methods (such as Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) are used to test serum samples. When the incorrect calibration is applied, the test produces falsely low folate values.
Affected lot numbers include 16275336, 21333336, 22318336, 23066336, 27947338, 62967344, and all higher lot numbers. The issue persists in both current and future lots until the manufacturer updates the Instructions for Use.
The recalled product
- Product
- ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10310308
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-error
- diagnostic-bias
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 (10)
- UDI: (01)00630414204192(10)16275336(17)20230320
- (01)00630414204192(10)21333336(17)20230320
- (01)00630414204192(10)22318336(17)20230320
- (01)00630414204192(10)23066336(17)20230320
- (01)00630414204192(10)27947338(17)20230529
- (01)00630414204192(10)62967344(17)20230726. Lot Numbers: 16275336
- 21333336
- 22318336
- 23066336
- 27947338
Distribution
Distributed nationwide across the United States.
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