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U.S. Department of Health and Human Services

Class 2 Device Recall Pentra 80XL

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 Class 2 Device Recall Pentra 80XLsee related information
Date Initiated by FirmAugust 13, 2004
Date PostedOctober 05, 2004
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0003-05
Recall Event ID 29830
510(K)NumberK024002 
Product Classification Counter, Differential Cell - Product Code GKZ
ProductAutomated Differential Cell Counter
Code Information Part Numbers: Pentra 80XL P80XL000NUA10 
Recalling Firm/
Manufacturer		 ABX Diagnostics Inc
34 Bunsen
Irvine CA 92618-4210
For Additional Information ContactT.M. Phillips
800-874-6218 Ext. 233
Manufacturer Reason
for Recall		Device can generate overestimated platelet results.
FDA Determined
Cause 2		Other
ActionSoftware problem, device may give overestimated platelet results.
Quantity in Commerce3
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.
510(K) Database510(K)s with Product Code = GKZ
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