Randox Laboratories Ltd.: Medical Device Recall in 2021 - (Recall #: Z-0328-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Product Classification:

Class II

Date Initiated: November 1, 2021

Date Posted: December 8, 2021

Recall Number: Z-0328-2022

Event ID: 88999

Reason for Recall:

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

Status: Terminated

Product Quantity: 15 kits

Code Information:

Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130

Distribution Pattern:

US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.

Voluntary or Mandated:

Voluntary: Firm initiated