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RANDOX LABORATORIES, LTD. recalls AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Recalled September 23, 2020 · FDA recall Z-2966-2020 · RANDOX LABORATORIES
Hazard
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. · FDA Class II
Units
143 kits in total
Sold at
US Distribution to states of: VA, UT, WV and country of : Canada
Description
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Product
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Manufacturer(s)
RANDOX LABORATORIES, LTD.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →