Events

Recall of VIGIL PROTEIN CONTROL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    39224
  • Event Risk Class
    III
  • Event Initiated Date
    2013-09-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter has confirmed differences in recovery of pfb in vigil protein control using pfb reagent lots m206298 m301364 m302049compared to values obtained using previous pfb reagent lots. these control differences are due to a change in the pool of antiserum material that is used in the manufacture of the pfb reagent. thecontrol range tables included in vigil protein control lots m210051 m210052 and m210053 do not reflect pfb values obtained with pfb reagent lots m206298 m301364 and m302049.

Device

VIGIL PROTEIN CONTROL
  • Model / Serial
    Model Catalog: 450130 (Lot serial: M210052(Level 2)); Model Catalog: 450125 (Lot serial: M210052(Level 2)); Model Catalog: 450120 (Lot serial: M210052(Level 2)); Model Catalog: 450130 (Lot serial: M210051(Level 1)); Model Catalog: 450120 (Lot serial: M210053(Level 3)); Model Catalog: 450120 (Lot serial: M210051(Level 1)); Model Catalog: 450130 (Lot serial: M210053(Level 3)); Model Catalog: 450125 (Lot serial: M210053(Level 3)); Model Catalog: 450125 (Lot serial: M210051(Level 1)); Model Catalog: 447760 (Lot serial: M302049); Model Catalog: 447760 (Lot serial: M301364); Model Catalog: 447760 (Lot serial: M206298)
  • Product Description
    Vigil Protein Control
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.