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Device Recall ABX PENTRA 400 I.S.E. Module
Model / Serial
Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. || Used to measure absorbance and ion electrodes.
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
1 Event
Recall of Device Recall ABX PENTRA 400 I.S.E. Module
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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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