Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-0905-2023)

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:

Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684

Product Classification:

Class II

Date Initiated: November 22, 2022

Date Posted: January 11, 2023

Recall Number: Z-0905-2023

Event ID: 91225

Reason for Recall:

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

Status: Ongoing

Product Quantity: 49 units US

Code Information:

GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.

Voluntary or Mandated:

Voluntary: Firm initiated