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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 FirmAugust 18, 2003
Date PostedJuly 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall NumberZ-1156-04
Recall Event ID 29114
510(K)NumberK010748 K973696 
Product Classification Folders And Injectors, Intraocular Lens (Iol) - Product Code MSS
ProductVigil 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 Commerce5275
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 = MSS
510(K)s with Product Code = MSS
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