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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm January 30, 2003
Date Posted March 29, 2003
Recall Status1 Terminated 3 on June 01, 2004
Recall Number Z-0692-03
Recall Event ID 25601
510(K)Number k922823  
Product Access 2 Immunoassay System
Code Information All fielded instruments.
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynne McBride
Manufacturer Reason
for Recall
False results from secondary pour off tubes
FDA Determined
Cause 2
Action Customers with the Access 2 instrument were informed of the recall issue by letter dated 1/30/2003. Those with the LXi 725 were informed by a letter dated 2/5/2003. The letters caution not to use certian Pour off tubes.
Quantity in Commerce 718
Distribution Nationwide and Canada

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 = and Original Applicant = BIO-RAD LABORATORIES, INC.