Device 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.

Z-2586-2017

March 13, 2012

Class II

Product summary

Firm: Medtest Holdings, Inc.
Event: Event 77003
Status: Terminated
Classification: Class II
Quantity: 270.36 L
Official record key: device-enforcement:Z-2586-2017

Official wording

Reason: Decrease reactivity of R 1 component.

Code information: Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Decrease reactivity of R 1 component.