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Class 2 Device Recall |
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Date Initiated by Firm |
May 06, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on November 30, 2004 |
Recall Number |
Z-0975-04 |
Recall Event ID |
29092 |
Product Classification |
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use - Product Code JQC
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Product |
Customized Automation Centrifuge, First and Second Generation. |
Code Information |
First Generation: OPIC0004, HAND0007, HAND0008, HAND0011, HAND0012, U9507151, U9507152, U9507153. Second Generation: 2028, 2030, 2032, 2033, 2034, 2038, 2039, 2040. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
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For Additional Information Contact |
Kathleen Jaker 714-961-3666
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Manufacturer Reason for Recall |
Centrifuge loss of containment with potential for injury or exposure to biohazard among lab workers.
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FDA Determined Cause 2 |
Other |
Action |
Recall was by letter and by telephone. All customers have been contacted. |
Quantity in Commerce |
17 |
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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