Apo B Reagent calibration error may produce inaccurate test results
Beckman Coulter is recalling Apo B Reagent due to an erroneous value in the calibration sheet that could generate incorrect patient test results with positive bias up to 42%.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition carries minimal risk of adverse health consequences. The source explicitly states the risk to health is "negligible or limited," and no illnesses or injuries are reported. Class III recalls are typically scored 1 or 2.
Plain-English summary
Beckman Coulter Ireland, Inc. is recalling Apo B Reagent (REF: OSR6143, Lot # 2631) used in device calibration. An erroneous value was included in the product's Value Assignment Sheet (VAS), which has the potential to generate incorrect Apo B patient test results.
The error could produce results that exceed the total allowable error threshold for the Apo B assay (11.6%), with a positive bias up to 42%. However, the manufacturer states that based on mitigating factors, the risk to health is considered negligible or limited.
The product was distributed worldwide, including US Nationwide distribution across Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia. Approximately 2,747 units were distributed.
Healthcare providers using this reagent should contact Beckman Coulter for guidance on calibration verification and appropriate remediation steps.
The recalled product
- Product
- Apo B Reagent, REF: OSR6143
- Manufacturer
- Beckman Coulter Ireland, Inc.
- Hazard
- calibration-error
- inaccurate-test-results
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)
- Lot # 2631/UDI: 15099590010409
Distribution
Distributed nationwide across the United States.
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