Company:Horiba Instruments, Inc dba Horiba Medical
Date of Enforcement Report 4/10/2013
Class ll:
PRODUCT
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. Recall Number Z-1050-2013
REASON
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
RECALLING FIRM/MANUFACTURER
Horiba Instruments, Inc dba Horiba Medical , Irvine, CA, on 2/15/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
180 units
DISTRIBUTION
Nationwide
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