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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmApril 08, 2004
Date PostedDecember 23, 2005
Recall Status1 Terminated 3 on February 06, 2006
Recall NumberZ-0298-06
Recall Event ID 29639
Product Classification Counter, Differential Cell - Product Code GKZ
ProductPentra 80 and Pentra 80XL Hematology Analyzers
Code Information All Serial numbers.
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information ContactTom Phillips
800-874-6218 Ext. 233
Manufacturer Reason
for Recall		Software defect, instrument may erroneously give a result of '0' or '---'.
FDA Determined
Cause 2		Other
ActionFirm sent a notification/recall letter on April 8, 2004. They plan to modify the software in August 2004.
Quantity in Commerce67
DistributionNationwide.
Total Product Life CycleTPLC 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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