Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2022-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633

Product Classification:

Class III

Date Initiated: May 4, 2023

Date Posted: July 5, 2023

Recall Number: Z-2022-2023

Event ID: 92344

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

Status: Ongoing

Product Quantity: 30 kits

Code Information:

GTIN: 05055273203837 Batch/Lot Number: 583135 Exp. Date: 28th April 23

Distribution Pattern:

CA, IL, VA, WA, WI including PR

Voluntary or Mandated:

Voluntary: Firm initiated