Cl II ABX PENTRA 400 and 400C

Company: Horiba Instruments Inc
Date of Enforcement Report 5/4/2016
Class lI:

PRODUCT

Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. Recall Number Z-1554-2016

REASON
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.

RECALLING FIRM/MANUFACTURER
Horiba Instruments Inc., Irvine, CA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
201

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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