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RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system is a device intended for the
Recalled August 12, 2020 · FDA recall Z-2753-2020 · RANDOX LABORATORIES
Hazard
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches. · FDA Class II
Sold at
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Description
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Product
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.
Manufacturer(s)
RANDOX LABORATORIES, LTD.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →