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Randox Laboratories Ltd. recalls This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox cali
Recalled September 18, 2019 · FDA recall Z-2490-2019 · Randox Laboratories
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). · FDA Class III
Units
307 kits
Sold at
Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago,
Description
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).
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.
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →