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U.S. Department of Health and Human Services

Class 2 Device Recall ABX Pentra ML

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  Class 2 Device Recall ABX Pentra ML see related information
Date Initiated by Firm September 20, 2012
Date Posted January 07, 2013
Recall Status1 Terminated 3 on March 12, 2013
Recall Number Z-0645-2013
Recall Event ID 63829
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Code Information Lot/Serial# PML0937
Recalling Firm/
Manufacturer		 Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact
949-453-0500 Ext. 208
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Software design
Action .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.
Quantity in Commerce 10 units
Distribution Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
Total Product Life Cycle TPLC Device Report
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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