FDA-Device2020-09-23Class II
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
RANDOX LABORATORIES, LTD.
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.
Sold states
US Distribution to states of: VA, UT, WV and country of : Canada
Affected count
143 kits in total
Manufactured in
34 Diamond Rd, N/A, Crumlin Colorado Antrim, N/A, United Kingdom
Products
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2020Don't want to check this manually?
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