Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0164-2016

U.S. FDA — Device Enforcement · Italy · 2015-09-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0164-2016
Date of alert
2015-09-22
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Sentinel CH SpA
Product category
device
Product type
Devices
Reported risk: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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