Events

Recall of Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB 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
    29114
  • Event Risk Class
    Class 3
  • Event Number
    Z-1156-04
  • Event Initiated Date
    2003-08-18
  • 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=33155
  • 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
    Folders And Injectors, Intraocular Lens (Iol) - Product Code MSS
  • Reason
    Values for apob were not properly assigned on the package insert. customers were not able to recover the analyte within the stated values.

Device

Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
  • Model / Serial
    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.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Product Description
    Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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