medical Class III Updated 2023-07-05

Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assa

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Affected States: CA, IL, VA, WA, WI
Lot/Code Info: GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23
View official government recall

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