RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for th…

Recall date

June 26, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2753-2020

FDA classification

Class II

Brand / firm

RANDOX LABORATORIES, LTD.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.

Why it was recalled

Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.