medical Class II Updated 2021-12-08

Randox Laboratories Ltd. recalls RANDOX CHOL-cholesterol (total) test system intended to meas

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
View official government recall

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