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
Check against the official notice below — it lists the full affected range.
Randox Laboratories Ltd. has recalled its Calibration Serum Level 3 calibration product used in clinical chemistry assays. The company realigned the RX Analyser Series calibration targets by 10% for AST (aspartate aminotransferase) and 9% for ALT (alanine aminotransferase) to align with the Mean of All Instrument method target. The recall affects 307 kits distributed nationwide and internationally to Antigua, Aruba, Bahamas, Granada, and Tobago, with lot numbers 961UE onwards.
The recall involves calibrator product with lot numbers 961UE and beyond, identified by GTN 05055273200966. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Nationwide Foreign: Antigua, Aruba, Bahamas, Granada, Tobago, Quantity: 307 kits Lot/code info: Lot Numbers: 961UE onwards GTN: 05055273200966
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.