Folate test kits recalled for calibration error causing inaccurate results
Siemens is recalling ADVIA Centaur Folate 500 test kits because a calibration error causes inaccurate, falsely low results when testing serum samples, potentially affecting diagnostic accuracy.
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: FDA Class II diagnostic device with a known calibration error causing measurement bias and inaccurate test results. Although no illnesses or injuries have been reported, the potential for patient harm through misdiagnosis of folate deficiency justifies a High severity rating.
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate 500 test kits used in clinical laboratories to measure folate levels in blood samples. The recall affects 124 kits distributed nationwide and internationally.
The issue is a calibration error: when whole blood calibration (from Atellica IM Fol or ADVIA Centaur FolateBA/FolBA assays) is incorrectly used to test serum samples, the test produces a negative bias—meaning folate results are inaccurately low. This can cause true folate levels to be underestimated in patient testing.
Affected lot numbers are 16277336, 23278336, 25958336, 63092344, and all higher lots. The manufacturer states that all current and future lots remain affected until the Instructions for Use are updated.
Laboratories using affected test kits should contact Siemens Healthcare Diagnostics for updated instructions and corrective guidance.
The recalled product
- Product
- ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10331250 Siemens Material Number (SMN): 10325366
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 124
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 (6)
- UDI: (01)00630414454597(10) 16277336(17)20230320
- (01)00630414454597(10) 23278336 (17)20230320
- (01)00630414454597(10)25958336(17)20230320
- (01)00630414454597(10)63092344(17)20230726. Lot Numbers: 16277336
- 23278336
- 25958336
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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