Recall Z-1424-2022— Randox Laboratories Ltd.

Name: FDA recall Z-1424-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-22

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2022-06-22, terminated 2024-05-10. It names one FDA 510(k) clearance: K923504. Product: Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0. Reason: 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..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2022-06-22
Terminated: 2024-05-10
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K923504 — CHOLESTEROL ENZYMATIC ENDPOINTRandox Laboratories, Ltd.·cleared 1994-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.