FDAJuly 12, 2019device

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration sera contain 42 analytes and are based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manua...

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

The hazard

Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for calibrator lot 961UE onwards).

What to do

FDA enforcement status: Terminated

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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