Events

Recall of PANOCELL-10 FICIN TREATED 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
    25049
  • Event Risk Class
    III
  • Event Initiated Date
    2018-01-30
  • 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 red blood cells treated with these ficin solution lots may fail to meet the 3 to 4+ result required when confirming ficin treatment with the ficin control. weak reactions obtained with the control test require repeat of the pre-modification procedure.

Device

PANOCELL-10 FICIN TREATED REAGENT RED BLOOD CELLS
  • Model / Serial
    Model Catalog: 0002385 (Lot serial: 50135-E); Model Catalog: 0002385 (Lot serial: 48110-E); Model Catalog: 0002385 (Lot serial: 38310-E); Model Catalog: 0002385 (Lot serial: 42355-E); Model Catalog: 0002385 (Lot serial: 40332-E); Model Catalog: 0002385 (Lot serial: 46089-E)
  • Product Description
    Panocell-10 Ficin Treated
  • Manufacturer
    DOMINION BIOLOGICALS LTD

Manufacturer

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