Date Initiated by Firm |
September 17, 2003 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on August 30, 2004 |
Recall Number |
Z-1115-04 |
Recall Event ID |
29072 |
Product Classification |
Calibrator, Primary - Product Code JIS
|
Product |
Synchron CX (and) Synchron LX Systems Microalbumin Calibrator. |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
Manufacturer Reason for Recall |
Sample values may be decreased by between 9 and 12 percent.
|
FDA Determined Cause 2 |
Other |
Quantity in Commerce |
NA, customer based action. |
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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