Date Initiated by Firm |
March 28, 2003 |
Date Posted |
May 09, 2003 |
Recall Status1 |
Terminated 3 on October 14, 2003 |
Recall Number |
Z-0805-03 |
Recall Event ID |
26040 |
Product Classification |
Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
|
Product |
COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use |
Code Information |
All existing versions of the software. Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact |
Lynn McBride 714-993-5321
|
Manufacturer Reason for Recall |
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
|
FDA Determined Cause 2 |
Other |
Action |
The firm sent notification letter and modified operating instructions by mail on March 28, 2003. |
Quantity in Commerce |
91 |
Distribution |
USA and Canada |
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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