Device Recall HITACHI DIRECT AND HITACHI TOTAL BILIRUBIN REAGENT

HB936-120, Lot Number: 731801, exp. 11/2011 and HB936-294, Lot Number: 817103, exp. 5/2012.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- USA, Chile and Mexico.

Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. || The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers.