Device product
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Z-0164-2016
Product summary
- Firm
- Sentinel CH SpA
- Event
- Event 72311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 765 kits
- Official record key
device-enforcement:Z-0164-2016
Official wording
Reason: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Code information: Lot 50083Y600, expiration date 31 Jul 2016.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.