Date Initiated by Firm |
August 13, 2004 |
Date Posted |
October 05, 2004 |
Recall Status1 |
Terminated 3 on September 02, 2005 |
Recall Number |
Z-0003-05 |
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 80XL P80XL000NUA10 |
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 |
3 |
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
|