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Device Recall ABX PENTRA Reagent Container
Model / Serial
Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide in US
Product Description
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
1 Event
Recall of Device Recall ABX PENTRA Reagent Container
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Manufacturer
Horiba Instruments, Inc dba Horiba Medical
Manufacturer Address
Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
Manufacturer Parent Company (2017)
Horiba Ltd.
Source
USFDA
Language
English
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