Date Initiated by Firm |
June 20, 2005 |
Date Posted |
August 16, 2005 |
Recall Status1 |
Terminated 3 on October 06, 2011 |
Recall Number |
Z-1372-05 |
Recall Event ID |
32558 |
Product Classification |
Calculator/Data Processing Module, For Clinical Use - Product Code JQP
|
Product |
DL 2000 Data Manager |
Code Information |
Not Applicable but refers to software version 6.4.109f |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
For Additional Information Contact |
Nancy Johnson 714-961-4489
|
Manufacturer Reason for Recall |
Version v6.4.109f, any result designated as 'calculated chemistry' at DL2000 may upload to the LIS with an incorrect or blank sample ID.
|
FDA Determined Cause 2 |
Other |
Action |
Recall letters were sent during the week of June 20, 2005. It explains the problem and indicates that an enclosed software correction must be installed to correct the problem. |
Quantity in Commerce |
287 |
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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