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/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
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For Additional Information Contact | Lynne McBride 714-961-3626 |
Manufacturer Reason for Recall | False results from secondary pour off tubes |
FDA Determined Cause 2 | Other |
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 |
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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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510(K) Database | 510(K)s with Product Code =
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