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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 February 14, 2014
Date Posted March 11, 2014
Recall Status1 Terminated 3 on August 22, 2014
Recall Number Z-1173-2014
Recall Event ID 67528
510(K)Number K053308  
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Device Name: ABX PENTRA ML
Model/Part #(s): A11A01652
Lot/Serial #(s): N/A
Software Version(s): All versions are subject to this correction.


Product Usage:
The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
Code Information Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A
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 initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
FDA Determined
Cause 2		 Software design
Action Horiba sent an "URGENT SAFETY NOTICE letter datedFebruary 13, 2014 via by mail to customers. The letter identified the affected product, issue, impact, actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory documentation. Customers were requested to complete and return the enclosed response form via one of the following methods: Fax: 949-453-0600 Email: jim.knowles@horiba.com Mail: HORIBA Medical Attention: Jim Knowles, Recall Coordinator 34 Bunsen Drive Irvine, CA 92618. For questions contact your local Horiba Medical representative.
Quantity in Commerce 15
Distribution USA Nationwide Distribution
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.
510(K) Database 510(K)s with Product Code = JQP and Original Applicant = HORIBA ABX
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