Randox Laboratories Ltd.: 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

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

Details from the source

Reason for recall: 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 Distribution: CA, IL, VA, WA, WI including PR Quantity: 1 kit Lot/code info: GTIN:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23

UPC codes

05055273203868

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.