FDA-Device2020-08-12Class II
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.
RANDOX LABORATORIES, LTD.
Hazard
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.
Affected count
2219 kits
Manufactured in
34 Diamond Rd, Crumlin Colorado Antrim, United Kingdom
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2751-2020Don't want to check this manually?
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