Jan

2013

Cl ll ABX PENTRA M

Company: Horiba Instruments, Inc dba Horiba Medical
Date of Enforcement Report 1/16/2013
Class ll:

PRODUCT

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Recall Number Z-0645-2013

REASON
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software versions are Versions 9.0.1, 9.0.2, 8.0x and below.

RECALLING FIRM/MANUFACTURER
Horiba Instruments, Inc dba Horiba Medical, Irvine, CA 9/20/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
10 units

DISTRIBUTION
Nationwide

___________________________________

About the author

Amy Sellers

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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Cl ll ABX PENTRA M

Amy Sellers

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