Siemens Atellica IM Folate 140 test kit recalled for measurement bias
Siemens is recalling the Atellica IM Folate 140 test kit due to negative bias that occurs when whole blood calibration is mistakenly used to test serum samples, potentially producing falsely low folate measurements.
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: This is an FDA Class II medical device with risk of harm from inaccurate diagnostic results (negative bias producing false-low folate measurements). No illnesses or injuries have been reported, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica IM Folate 140 test kit, an in vitro diagnostic device used to measure folate levels in human serum and red blood cells. The recall affects approximately 13,843 kits distributed nationwide and internationally, including lot numbers 15308337, 27949339, 41143343, 41144343, 62969345, and higher.
The device was recalled due to negative bias that occurs when whole blood calibration (from Atellica IM Folate or ADVIA Centaur FolateBA/FolBA) is used instead of serum calibration to test serum samples. This results in falsely low folate measurements, which could lead to missed diagnoses or inadequate treatment of folate deficiency.
Healthcare facilities and laboratory professionals using this test kit should stop using affected lots and contact Siemens Healthcare Diagnostics for further guidance. The recall affects all current and future lots until the Instructions for Use are updated with corrected procedures. No illnesses or injuries have been reported at this time.
The recalled product
- Product
- Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells. Siemens Material Number (SMN): 10995572
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- measurement-bias
- false-negative
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 (3)
- 27949339
- 41143343
- 41144343
Distribution
Distributed nationwide across the United States.
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