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/ Manufacturer |
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 | Other |
Action | Software problem, device may give overestimated platelet results. |
Quantity in Commerce | 91 |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = GKZ
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