Events

Recall of CD7 ANTIBODY LIQUID MONOCLONAL

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LEICA MICROSYSTEMS CANADA.

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
    41842
  • Event Risk Class
    II
  • Event Initiated Date
    2012-01-10
  • 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
    Leica biosystems recently became aware that in various lots the primary antibodies to cd2 (clone 11f11) and cd7 (clone lp15) have been adulterated. based on their investigations the product labelled as cd2 is actually cd7 antibody and respectively the product labelled as cd7 is cd2 antibody.

Device

CD7 ANTIBODY LIQUID MONOCLONAL
  • Model / Serial
    Model Catalog: NCL-L-CD7-580 (Lot serial: L158020); Model Catalog: PA0266 (Lot serial: 10604); Model Catalog: NCL-L-CD7-580 (Lot serial: L158019); Model Catalog: NCL-L-CD7-580 (Lot serial: L158018)
  • Product Description
    CD7 ANTIBODY LIQUID MONOCLONAL
  • Manufacturer
    LEICA MICROSYSTEMS CANADA

Manufacturer

LEICA MICROSYSTEMS CANADA