Events

Recall of CAPTURE-R READY-ID

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IMMUCOR 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
    22931
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-25
  • 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
    Immucor has received reports that plates of capture-r ready-id (lot id 296) are being aborted due to "measurement out of range" errors after the strip clean read on the galileo neo instrument due to cell 13 exhibiting a yellow color.

Device

CAPTURE-R READY-ID
  • Model / Serial
    Model Catalog: 0066214 (Lot serial: Lot: ID296/Exp:2016-05-31)
  • Product Description
    Capture-R Ready-ID
  • Manufacturer
    IMMUCOR INC.

Manufacturer

IMMUCOR INC.
  • Manufacturer Address
    NORCROSS
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC