ADVIA Centaur Folate 500 test kits recalled for inaccurate measurement results
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 diagnostic test kits because using whole blood calibration with serum samples produces negative bias and inaccurate 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 3/5 (High).
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: This FDA Class II device recall presents a risk of inaccurate diagnostic results through procedural error. Incorrect calibration approach can lead to underestimation of folate levels and missed diagnoses. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 7,884 ADVIA Centaur Folate 500 test kits distributed nationwide and internationally. These are in vitro diagnostic test kits designed to measure folate levels in human serum and red blood cells.
When whole blood calibration solutions (from Atellica IM Fol or ADVIA Centaur FolateBA/FolBA instruments) are used to test serum samples, the results exhibit negative bias—meaning folate levels are underestimated. This can lead to inaccurate folate measurements and may result in missed diagnoses of folate deficiency.
The recall applies to affected lot numbers 16276336, 21334336, 22079336, 27946338, 41225342, 62966344, and all higher lot numbers. Healthcare facilities and clinical laboratories using these kits should verify they are using the correct calibration approach for the sample type being tested. The manufacturer plans to update the Instructions for Use to prevent this issue.
The recalled product
- Product
- ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10325366
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 7,884
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 (11)
- UDI: (01)00630414450940(10)16276336 (17)20230320
- (01)00630414450940(10)21334336(17)20230320
- (01)00630414450940(10)22079336(17)20230320
- (01)00630414450940(10)27946338(17)20230529
- (01)00630414450940(10)41225342(17)20230630
- (01)00630414450940(10)62966344 (17)20230726
- Lot Numbers: 16276336
- 21334336
- 22079336
- 27946338
- 41225342
Distribution
Part of a larger recall action
This product is one of 6 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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