Devices

Device Recall Pointe Scientific Hitachi AST Reagent

Model / Serial
Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide Distribution
Product Description
Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.
Manufacturer
Medtest Holdings, Inc.
1 Event
- Recall of Device Recall Pointe Scientific Hitachi AST 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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