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 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
    16127
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-19
  • 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 inc. (manufacturer of the device) notified dominion biologicals limited of the intent to initiate a market withdrawal of cell 4 included in the panocell-10 ficin-treated lot 38324-e. cell 4 (donord1377) on this panel is listed as s+s- on the master list. in response to a report of unexpected negative reactivity on untreated cell 4 we have reproduced the customer's reported results. cell 4 has demonstrated reactivity varying from negative to 3+ using different sources of anti-s. cell 4 is one of four s+ red blood cells on this panel: cells 2 7 and 9 are also s+. cell 4 is the only s+s- cell on this panel.

Device

PANOCELL-10 FICIN TREATED REAGENT RED BLOOD CELLS
  • Model / Serial
    Model Catalog: 0002385 (Lot serial: 38324-E)
  • Product Description
    Panocell-10 Ficin-Treated
  • Manufacturer
    IMMUCOR INC.

Manufacturer

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