Beckman Coulter UIBC Assay Not Meeting Labeled Hemoglobin Interference Claims
Beckman Coulter's UIBC assay does not meet its labeled performance claims for hemoglobin interference. Testing showed up to 43.6% negative bias in low UIBC samples at 200 mg/dL hemoglobin, versus the claimed <10% interference limit.
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 a Class II FDA recall involving a diagnostic assay with significant analytical bias (up to 43.6%) that could affect patient care through misdiagnosis. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product without reported injury corresponds to a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the UIBC (Unsaturated Iron Binding Capacity) assay, REF OSR61205, a clinical laboratory test used to measure iron-binding capacity in patient blood samples. Approximately 56,696 units have been distributed throughout the United States and over 50 countries worldwide.
The company identified that the assay does not meet its labeled performance specifications regarding hemoglobin interference. The assay instructions claim no significant interference (less than 10%) from hemoglobin up to 200 mg/dL, but internal testing revealed that samples with low UIBC levels in the presence of 200 mg/dL hemoglobin showed negative biases as high as -43.6%, substantially exceeding the claimed specification.
Inaccurate test results could lead to misdiagnosis or incorrect clinical decisions by healthcare providers. The FDA classified this as a Class II recall. Laboratories using this reagent should contact Beckman Coulter for guidance. No patient illnesses or injuries have been reported associated with this issue.
The recalled product
- Product
- UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- analytical-bias
- hemoglobin-interference
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 (1)
- All Lots/(01)15099590011925
Distribution
Distributed in 9 states:
- AK
- AL
- AR
- CO
- CT
- DC
- DE
- ID
- UT
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03