Sentinel CH SpA recalls Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intende…

Recall date

September 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0164-2016

FDA classification

Class II

Brand / firm

Sentinel CH SpA

Sold / distributed

Nationwide Distribution.

Why it was recalled

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.