Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1328-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

Product Classification:

Class II

Date Initiated: March 1, 2024

Date Posted: March 27, 2024

Recall Number: Z-1328-2024

Event ID: 94187

Reason for Recall:

The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

Status: Ongoing

Product Quantity: 1,764 units

Code Information:

Catalog No. IT2691; GTIN 05055273204032; Batch No./Lot No. (Exp. Date): 647343/2154IT-2158IT (03/28/25), 647342/2154IT-2158IT (03/28/25), 634886/2112IT-2116IT (07/28/24), 634887/2112IT-2116IT (07/28/24), 627224/2112IT-2116IT (07/28/24), 627222/2112IT-2116IT (07/28/24)

Distribution Pattern:

Domestic: CA, FL, IL, ME, NJ, OH, & OR.

Voluntary or Mandated:

Voluntary: Firm initiated