Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-1050-2013

Z-1050-2013 Class III Terminated

Recalled by Horiba Instruments, Inc dba Horiba Medical — Irvine, CA

Recall Details

Product Type
Devices
Report Date
April 10, 2013
Initiation Date
February 15, 2013
Termination Date
August 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
180 units

Product Description

ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.

Reason for Recall

Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.

Distribution Pattern

Nationwide Distribution

Code Information

All serial numbers

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