Events

Recall of SSP UNITRAY - HIGH RESOLUTION CLASS II

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
    44732
  • Event Risk Class
    III
  • Event Initiated Date
    2012-11-07
  • 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 drb1*04 ssp unitray kit has a false negative in lane 9 which gives no perfect match typing result for the drb1 *04:32 allele. internal investigation has confirmed with the now available rare sample type that lane 9 is false negative for the drb1 *04:32 allele in the listed affected kit according to the labeling provided with the kit. product does not meet specification. however the primer mix in lane 9 is functioning as originally intended. the drb1*04:32 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 45040-4 (Lot serial: 010 666807); Model Catalog: 45040-4 (Lot serial: 010 727196); Model Catalog: 45040-4 (Lot serial: 011 989163)
  • Product Description
    DRB1 *04 SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION