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FDAFebruary 3, 2025device

HemosIL LMW Heparin Controls; Part Number: 0020300200;

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

The hazard

Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and HemosIL Heparin Calibrator. In some complaints, failure to pass QC resulted in patient testing delays.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

08426950472490

Recall history

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

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