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FDAApril 23, 2025device

Apo B Reagent, REF: OSR6143

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

beckman coulter irelandbeckmanbeckman coulter

UPCs

15099590010409

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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