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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 August 18, 2003
Date Posted July 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1156-04
Recall Event ID 29114
510(K)Number k973696  k010748  
Product Classification Folders And Injectors, Intraocular Lens (Iol) - Product Code MSS
Product Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
Code Information CX: Level 1 -M206191, Level 2-M206192, Level 3-M206193, Level 4-M206194. LX: Level 1-M301121, Level 2- M301122, Level 3- M301122, Level 4-M301124.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		 Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values.
FDA Determined
Cause 2		 Other
Quantity in Commerce 5275
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.
510(K) Database 510(K)s with Product Code = MSS and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = MSS and Original Applicant = BECKMAN INSTRUMENTS, INC.
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