Date Initiated by Firm |
September 18, 2003 |
Date Posted |
November 06, 2003 |
Recall Status1 |
Terminated 3 on March 30, 2004 |
Recall Number |
Z-0096-04 |
Recall Event ID |
27432 |
510(K)Number |
k965240 k014034 k011213 k014034 k023049
|
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
Synchron CX Systems version 4.0 Operating Software used in Synchron LX20 Systems, Synchron LX20 Pro Systems, Synchron LXi Systems. |
Code Information |
All those with version 4.0 operating software. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd Brea CA 92821
|
For Additional Information Contact |
Kathleen Jaker 714-961-3666
|
Manufacturer Reason for Recall |
Sample wheel may home to the wrong position.
|
FDA Determined Cause 2 |
Other |
Action |
Recall is accomplished by telephone and by letter. Telephone calls were made by 9/24/2003. All customers have been notified by telephone. |
Quantity in Commerce |
154 |
Distribution |
Nationwide 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.
|
510(K) Database |
510(K)s with Product Code = JQP and Original Applicant = BECKMAN COULTER, INC. 510(K)s with Product Code = JQP and Original Applicant = BECKMAN INSTRUMENTS, INC.
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