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FDANovember 13, 2023device

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level 3 (HE 1532)

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

The hazard

There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the IFU of Human Assayed Multi-Sera Level 2 (HN1530) for TBIC taget value and on IFU of Human Assayed Multi-Sera Level 3 (HE 1532) for Lipase target value.

What to do

FDA enforcement status: Ongoing

Brands named

randox laboratoriesrandox

UPCs

05055273200966

Recall history

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

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