Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-0992-2024)

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:

RX Series Copper (Cu) Assay Ref. Number CU2340

Product Classification:

Class II

Date Initiated: November 29, 2023

Date Posted: February 14, 2024

Recall Number: Z-0992-2024

Event ID: 93775

Reason for Recall:

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Status: Ongoing

Product Quantity: 3,053 kits (2 US, 3,051 OUS)

Code Information:

Catalogue Number/GTIN: CU2340 05055273201949; Lot/batch: 592278, 610661, 610669, 629021, 647201, 657944;

Distribution Pattern:

US Nationwide distribution in the states of SC and OK.

Voluntary or Mandated:

Voluntary: Firm initiated