Device product
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Z-2966-2020
Product summary
- Event
- Event 86238
- Status
- Terminated
- Classification
- Class II
- Quantity
- 143 kits in total
- Official record key
device-enforcement:Z-2966-2020
Official wording
Reason: 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.
Code information: Catalogue Number: AM1054 GTIN: 05055273200263 Lot #: 512103 batch 512103
Distribution pattern: US Distribution to states of: VA, UT, WV and country of : Canada
Derived failure modes
-
Unknown
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.