Randox Laboratories Ltd. recalls This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox cal…

Recall date

July 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2490-2019

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,

Why it was recalled

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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.