Siemens Atellica IM Folate 700 test kit recalled for measurement bias
Siemens Healthcare is recalling 9,272 Atellica IM Folate 700 test kits due to negative bias in results when whole blood calibration is used to test serum samples.
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 is a Class II recall involving a diagnostic test with measurement inaccuracy. Although no illnesses or injuries have been reported, the negative bias in test results represents a risk-of-harm situation, as inaccurate folate measurements could lead to missed diagnoses or incorrect clinical decisions.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 9,272 Atellica IM Folate 700 test kits. These kits are in vitro diagnostic devices used in clinical laboratories to measure folate levels in human serum and red blood cells.
The recall was issued because negative bias occurs when whole blood calibration (used in Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) is incorrectly used to test serum samples. This results in falsely low measurements, which could lead to misdiagnosis or incorrect clinical decisions.
Affected lot numbers include 15307337, 27948339, 41142343, 62968345, and higher. The kits have been distributed nationwide and internationally. Healthcare providers using these test kits should contact Siemens Healthcare Diagnostics for guidance on affected lots.
The recalled product
- Product
- Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995573
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 9,272
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)00630414598970(10)15307337(17)20230320
- (01)00630414598970(10)27948339(17)20230529
- (01)00630414598970(10)41142343(17)20230630
- (01)00630414598970(10)62968345(17)20230726. Lot Numbers: 15307337
- 27948339
- 41142343
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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