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Sentinel CH SpA recalls Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended
Recalled November 4, 2015 · FDA recall Z-0164-2016 · Sentinel CH SpA
Hazard
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. · FDA Class II
Units
765 kits
Sold at
Nationwide Distribution.
Description
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
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.
Manufacturer(s)
Sentinel CH SpA
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →