Devices

Device Recall Pointe Scientific Hitachi Total Bilirubin Rl Reagent

Model / Serial
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.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE
Product Description
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.
Manufacturer
Medtest Holdings, Inc.
1 Event
- Recall of Device Recall Pointe Scientific Hitachi Total Bilirubin Rl Reagent

Manufacturer

Medtest Holdings, Inc.

Manufacturer Address
Medtest Holdings, Inc., 5449 Research Dr, Canton MI 48188-2261
Manufacturer Parent Company (2017)
Medtest Holdings Inc
Source
USFDA

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