Randox Laboratories Ltd.: Medical Device Recall in 2022 - (Recall #: Z-1424-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

Product Classification:

Class II

Date Initiated: June 22, 2022

Date Posted: July 27, 2022

Recall Number: Z-1424-2022

Event ID: 90522

Reason for Recall:

Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.

Status: Terminated

Product Quantity: 15 kits

Code Information:

GTIN : 05055273201130 Lot Number: 586177 Expiry Date: 28th Jan 2024

Distribution Pattern:

Nationwide Distribution - MD, OR, PR, MT, WV

Voluntary or Mandated:

Voluntary: Firm initiated