Events

Recall of Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    29103
  • Event Risk Class
    Class 3
  • Event Number
    Z-1155-04
  • Event Initiated Date
    2003-08-15
  • Event Date Posted
    2004-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33141
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Test, Low Density, Lipoprotein - Product Code MRR
  • Reason
    Ldl cholesterol component in controls are unstable.

Device

Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent
  • Model / Serial
    CX: Level 1-M206161, Level 2-M206192, Level 4-M206194. LX Level 1-M301021, Level 2-M301122, Level 4-M301124.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Product Description
    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)
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA