Beckman Coulter Ireland, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Beckman Coulter Ireland, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-06-04FDA-DeviceClass IIIApo B Reagent, REF: OSR6143
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
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