Home / Recalls / Medical Devices
RANDOX LABORATORIES, LTD. recalls Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a device intended for the quan
Recalled August 12, 2020 · FDA recall Z-2751-2020 · RANDOX LABORATORIES
Hazard
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches. · FDA Class II
Units
2219 kits
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 reagent batches.
Product
Randox Lipase Assay: Lipase Colorimetric Reagent - 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 →