Randox Laboratories Ltd. recalls Immunoassay Premium Plus Controls, Model Numbers IA3109 and
Recalled Product
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 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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