FDA recall Z-2965-2020

RANDOX LABORATORIES, LTD. · Class II · device

Product

AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Reason for recall

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.

Distribution

US Distribution to states of: VA, UT, WV and country of : Canada

Key facts

Status
Terminated
Initiation date
2020-07-30
Report date
2020-09-23
Termination date
2021-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin Colorado Antrim, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2965-2020