Recall Z-0328-2022— Randox Laboratories Ltd.

Name: FDA recall Z-0328-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-01

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2021-11-01, terminated 2023-03-09. It names one FDA 510(k) clearance: K923504. Product: RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200. Reason: 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.

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2021-11-01
Terminated: 2023-03-09
Firm location: Crumlin (North), 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 CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

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

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