FDA recall Z-2586-2017

Product

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.

Reason for recall

Decrease reactivity of R 1 component.

Distribution

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

Key facts

Status

Terminated

Initiation date

2012-03-13

Report date

2017-06-21

Termination date

2017-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canton, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2586-2017