Medtest Holdings, Inc. recalls Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin…

Recall date

March 13, 2012

Source

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

Recall number

Z-2586-2017

FDA classification

Class II

Brand / firm

Medtest Holdings, Inc.

Sold / distributed

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

Why it was recalled

Decrease reactivity of R 1 component.

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

What was recalled

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.