Events

Recall of PANOCELL-10 (2-4% SUSPENSION) REAGENT RED BLOOD CELLS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DOMINION BIOLOGICALS LTD.

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
    144959
  • Event Risk Class
    II
  • Event Initiated Date
    2010-05-10
  • 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
    The master list packaged with panocell-10 (lot 13083) contains a typographical error in the antigen typing listed for cell 5 (donor e791). the donor e791 typing is incorrectly listed as positive for the f antigen. the antifen status for donor e791 should be listed as f negative.

Device

PANOCELL-10 (2-4% SUSPENSION) REAGENT RED BLOOD CELLS
  • Model / Serial
    Model Catalog: 0003032 (Lot serial: 13083)
  • Product Description
    Immucor Panocell-10
  • Manufacturer
    DOMINION BIOLOGICALS LTD

Manufacturer

DOMINION BIOLOGICALS LTD
  • Manufacturer Address
    DARTMOUTH
  • Manufacturer Parent Company (2017)
    Ivd Holdings Inc
  • Source
    HC