Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-1759-2024)

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:

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.

Product Classification:

Class II

Date Initiated: March 5, 2024

Date Posted: May 15, 2024

Recall Number: Z-1759-2024

Event ID: 94358

Reason for Recall:

Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.

Status: Ongoing

Product Quantity: 80,366 units (US: 242 units; OUS: 80,094 units)

Code Information:

Catalogue No. CAL2351 & CAL10388; GTIN: 05055273200966; Lot No. 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, 1326UE, 1295UE, & 1325UE.

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated