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U.S. Department of Health and Human Services

Class 3 Device Recall ABX Micros IM2

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 Class 3 Recall
ABX Micros IM2
see related information
Date Posted April 03, 2013
Recall Status1 Terminated on August 11, 2014
Recall Number Z-1050-2013
Recall Event ID 64386
Product Classification Calculator/Data Processing Module, For Clinical Use - Product Code JQP
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine, California 92618-4210
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action Horiba Medical sent an Urgent Safety Notice dated February 15, 2013, to all affected customers. The letter informed the customers that Horiba Medical is informing all ABX Micros IM2 Data Management System customers of their intention to remove the ABX Micros IM2 product from the market. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. For questions regarding this recall call 949-453-0500, ext 208.
Quantity in Commerce 180 units
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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