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
    15528
  • Event Risk Class
    III
  • Event Initiated Date
    2012-09-18
  • 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
    The a19 allset gold ssp kit has a false negative in lane 30 for the a*74:06 allele that will cause a no typing result. internal investigation has confirmed that primer mix a 74-01 found on lane 30 in the a19 allset gold and ssp unitray kits gives a false negative for the a*74:06 allele according to the documentation within the kits. however the primer mix a 74-01 is functioning as originally designed. a human error resulted in a manual change of the a 74-01 primer mix to be listed as positive for the a*74:06 allele within kit documentation and the kit .Uch file.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 472104D (Lot serial: 007 871220); Model Catalog: 472104D (Lot serial: 007 678899); Model Catalog: 472104D (Lot serial: 007 1103714); Model Catalog: 472104D (Lot serial: 007 793333)
  • Product Description
    A19 SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION