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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 28, 2004
Date Posted July 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1149-04
Recall Event ID 28965
Product Classification Immunoelectrophoretic, Immunoglobulins, (G, A, M) - Product Code CFF
Product IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit.

Part Numbers:
446360 (250 test kit)
446260 (50 test kit)
444970 (10 test kit)
Code Information M308363 (250 test) M309039 (50 test)  10 test-- M307327, m307329, M307333, M310301, M310302, M310303, M310304, M310305, M305176.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		 Inconsistent and incomplete results for IgG.
FDA Determined
Cause 2		 Other
Total Product Life Cycle TPLC 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.
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