Events

Recall of CALIBRATION VERIFICATION ASSESSMENT (CVA)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SOMAGEN DIAGNOSTICS 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
    109331
  • Event Risk Class
    III
  • Event Initiated Date
    2008-12-05
  • 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
    Lot 8287 assay has been revised for lh750rbc lh750plt lh500plt. recent calibration studies conducted by streck have confirmed differences between manufacturer's calibrators and those using whole blood calib.

Device

CALIBRATION VERIFICATION ASSESSMENT (CVA)
  • Model / Serial
    Model Catalog: (Lot serial: 8287)
  • Product Description
    Calibration Verification Assessment
  • Manufacturer
    SOMAGEN DIAGNOSTICS INC.

Manufacturer

SOMAGEN DIAGNOSTICS INC.
  • Manufacturer Address
    EDMONTON
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC