Events

Recall of PANOCELL-16 (2-4% SUSPENSION) REAGENT RED BLOOD 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
    52753
  • Event Risk Class
    II
  • Event Initiated Date
    2013-03-14
  • 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 confirmed variable weak reactivity of the js(a) antigen on cell 2 (donor b5415) of panocell-16 (lot 52107). this has resulted in unexpected weak and negative reactions when testing this cell with various examples of anti-jsa during the shelf life of the product.

Device

PANOCELL-16 (2-4% SUSPENSION) REAGENT RED BLOOD CELLS
  • Model / Serial
    Model Catalog: 0002332 (Lot serial: Lot 52107)
  • Product Description
    Panocell-16
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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