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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-1146-04
Recall Event ID 28963
510(K)NumberK993547 
Product Classification Method, Nephelometric, Immunoglobulins (G, A, M) - Product Code CFN
ProductIMMAGE IGALC Reagent Part Number: 447460
Code Information Lots prior to M303259
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).
FDA Determined
Cause 2		Other
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 = CFN
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