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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmJanuary 30, 2003
Date PostedMarch 29, 2003
Recall Status1 Terminated 3 on June 01, 2004
Recall NumberZ-0692-03
Recall Event ID 25601
510(K)NumberK922823 
ProductAccess 2 Immunoassay System
Code Information All fielded instruments.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactLynne McBride
714-961-3626
Manufacturer Reason
for Recall		False results from secondary pour off tubes
FDA Determined
Cause 2		Other
ActionCustomers 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 Commerce718
DistributionNationwide 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) Database510(K)s with Product Code =
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