Class 3 Device Recall

• Date Initiated by Firm: August 15, 2003
• Date Posted: July 23, 2004
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.