Randox Laboratories Ltd. recalls Immunoassay Premium Controls, Model Numbers IA2633 and IA263
Recalled Product
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Hazard / Issue
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Issued by
FDA
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