Events

Recall of SSP UNITRAY - HIGH RESOLUTION CLASS I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIFE TECHNOLOGIES CORPORATION.

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
    16132
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-01
  • 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
    One complaint regarding this issue has been received. complaint states the b*35 aiiset gold ssp kit has a false negative in lane 8 which gives no perfect match typing result for the b*35:116 allele. internal investigation has confirmed with the now available rare sample type that lane 8 is negative for the b*35: 116 allele in the above listed affected kits according to the labeling provided with the kits. the primer mixes had not been tested with a b*35: 116 sample the labeling stated the primers in lane 8 would amplify the targeted sequences in the b*35: 116 allele.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 471006D (Lot serial: 008 884116)
  • Product Description
    B*35 SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION