medical Class III Updated 2019-09-18

Randox Laboratories Ltd. recalls This is an in vitro diagnostic product intended for use as a

Recalled Product

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 manually and on a wide range of automatic analyzers. Constituent concentrations are available at 2 levels.


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 961UE onwards GTN: 05055273200966
View official government recall

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