Randox Laboratories, Limited: Medical Device Recall in 2025 - (Recall #: Z-1017-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

Product Classification:

Class II

Date Initiated: December 20, 2024

Date Posted: January 29, 2025

Recall Number: Z-1017-2025

Event ID: 96043

Reason for Recall:

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Status: Ongoing

Product Quantity: 15 kits

Code Information:

UDI-DI: 05055273204421 All lots within expiry

Distribution Pattern:

US Nationwide distribution Including PR.

Voluntary or Mandated:

Voluntary: Firm initiated