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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm June 04, 2003
Date Posted August 21, 2003
Recall Status1 Terminated 3 on June 17, 2014
Recall Number Z-1149-03
Recall Event ID 26431
510(K)Number K003677  
Product Classification Counter, Differential Cell - Product Code GKZ
Product ABX Diagnostices Pentra 60C+ Hematology Analyzer
Code Information Software versions of up to 1.7
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen Drive
Irvine CA 92618
For Additional Information Contact Tom Phillips
949-453-0500 Ext. 233
Manufacturer Reason
for Recall		 Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
FDA Determined
Cause 2		 Other
Action The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.
Quantity in Commerce 159
Distribution Nationwide.
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 = GKZ and Original Applicant = ABX DIAGNOSTICS
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