Events

Recall of CHECKCELLS (POOLED CELLS)

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
    60042
  • Event Risk Class
    III
  • Event Initiated Date
    2016-09-15
  • 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
    On sept. 14 2016 immucor inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a medical device recall on checkcell. immucor has received customer complaints of increased hemolysis seen in some vials of this lot. immucor's internal investigation has confirmed an increase in hemolysis in their remaining product inventory. immucor has performed additional serological testing on retention samples of lot 31864 and the reagent continues to meet reactivity specifications. immucor has indicated that testing results using this lot are valid provided the reagent meets the requirements for reactivity described in the quality control section of the package insert. the package insert also cautions the user that: antiglobulin control cells should not be used if the cells darken spontaneously clump or if there is significant hemolysis.

Device

CHECKCELLS (POOLED CELLS)
  • Model / Serial
    Model Catalog: 0002224 (Lot serial: 31864); Model Catalog: 0002225 (Lot serial: 31864)
  • Product Description
    Checkcell
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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