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Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH

Recalled July 27, 2022 · FDA recall Z-1424-2022 · Randox Laboratories

Hazard
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. · FDA Class II
Units
15 kits
Sold at
Nationwide Distribution - MD, OR, PR, MT, WV

Description

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.

Product
Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0
Manufacturer(s)
Randox Laboratories Ltd.
Made in
Ireland

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH | RecallWatchUSA