Randox Laboratories Ltd.: Medical Device Recall in 2024 - (Recall #: Z-2425-2024)

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 CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004

Product Classification:

Class II

Date Initiated: June 7, 2024

Date Posted: July 31, 2024

Recall Number: Z-2425-2024

Event ID: 94858

Reason for Recall:

Cystatin C Reagent marketed without a 510 (k)

Status: Ongoing

Product Quantity: 115 kits

Code Information:

GTIN: 05055273208665 All lots

Distribution Pattern:

US Nationwide distribution in the states of AL, CA, GA, NY.

Voluntary or Mandated:

Voluntary: Firm initiated