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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 FirmJune 06, 2003
Date PostedJuly 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall NumberZ-1150-04
Recall Event ID 29094
510(K)NumberK963868 
Product Classification Igg, Antigen, Antiserum, Control - Product Code DEW
ProductIMMAGE IgM Reagent Part No.: 447610
Code Information Lots M210213, M303183
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.
FDA Determined
Cause 2		Other
Quantity in Commerce10,000
Total Product Life CycleTPLC Device Report
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 = DEW
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