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U.S. Department of Health and Human Services

Class 2 Device Recall Pentra 80

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  Class 2 Device Recall Pentra 80 see related information
Date Initiated by Firm August 13, 2004
Date Posted October 05, 2004
Recall Status1 Terminated 3 on September 02, 2005
Recall Number Z-0002-05
Recall Event ID 29830
510(K)Number K024002  
Product Classification Counter, Differential Cell - Product Code GKZ
Product Automated Differential Cell Counter
Code Information Part Numbers: Pentra 80 P8000000NUA10 
Recalling Firm/
ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact T.M. Phillips
800-874-6218 Ext. 233
Manufacturer Reason
for Recall
Device can generate overestimated platelet results.
FDA Determined
Cause 2
Action Software problem, device may give overestimated platelet results.
Quantity in Commerce 91
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