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FDANovember 1, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

UPCs

05055273201130

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200 — Recall Details · AllClear