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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 24, 2004
Date Posted August 13, 2004
Recall Status1 Terminated 3 on September 02, 2005
Recall Number Z-1342-04
Recall Event ID 29700
510(K)Number K022200  
Product Classification Stain, Reticulocyte - Product Code GJH
Product PENTRA 120 and PENTRA 120 Retic Hematology Analyzer
Code Information Any instrument which is not equipped with v4.55 or above will be upgraded.
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact Tom Phillips
949-453-0500
Manufacturer Reason
for Recall		 Power failure having impact on software.
FDA Determined
Cause 2		 Other
Action Firm sent a notification / recall letter and response card dated June 24,2004 and promised to provide software shortly.
Quantity in Commerce 81
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 = GJH and Original Applicant = ABX DIAGNOSTICS
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