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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 15, 2003
Date Posted July 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall Number Z-1155-04
Recall Event ID 29103
510(K)Number k973696  k010748  
Product Classification System, Test, Low Density, Lipoprotein - Product Code MRR
Product Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent

Part No.: 469905 Lot M206161 (level 1)
Part No.: 465980 Lot M206192 (level 2)
Part No.: 465982 Lot M206194 (level 4)
Part No.: 465421 Lot M301121 (level 1)
part No.: 465422 Lot M301122 (level 2)
Part No.: 465424 Lot M301124 (level 4)
Code Information CX: Level 1-M206161, Level 2-M206192, Level 4-M206194. LX Level 1-M301021, Level 2-M301122, Level 4-M301124.
Recalling Firm/
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall
LDL Cholesterol component in controls are unstable.
FDA Determined
Cause 2
Quantity in Commerce 1780 all lots.
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 = MRR and Original Applicant = BECKMAN COULTER, INC.
510(K)s with Product Code = MRR and Original Applicant = BECKMAN INSTRUMENTS, INC.