Randox Laboratories Ltd. recalls Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro…

Recall date

February 7, 2019

Source

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

Recall number

Z-1106-2019

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

The products were distributed to the following US states: WV and Puerto Rico.

Why it was recalled

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.

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

What was recalled

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