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FDAJune 26, 2020device

Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

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

The hazard

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.

What to do

FDA enforcement status: Terminated

Brands named

randox laboratoriesrandox

Recall history

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

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