| Class 3 Device Recall ABX Micros IM2 | |
Date Initiated by Firm | February 15, 2013 |
Date Posted | April 03, 2013 |
Recall Status1 |
Terminated 3 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
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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 CA 92618-4210
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For Additional Information Contact | 949-453-0500 Ext. 208 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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