Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and re…

Recall date

May 4, 2023

Source

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

Recall number

Z-2021-2023

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

CA, IL, VA, WA, WI including PR

Why it was recalled

Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range

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

What was recalled

Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640