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
    22791
  • Event Risk Class
    II
  • Event Initiated Date
    2012-02-14
  • 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 kits will produce an incorrect typing or mistyping result of a c*07:18 allele when testing a sample which has a c*07:01:03 allele. primer mix c07-06b found on lane 42 in the cw high resolution allset gold and ssp unitray high resolution kits was found to contain a false positive for c*07:01:03. c*07:01:03 has an unknown sequence at the priming site and was incorrectly predicted to be negative in lane 42 in the kit documentation. after analysis we have confirmed that lane 42 now amplifies the c*07:01:03 allele. this discrepancy does not result in a common allele mistyping.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 47190-10 (Lot serial: 005 791450); Model Catalog: 47190-10 (Lot serial: 005 839297); Model Catalog: 47190-10 (Lot serial: 005 889242); Model Catalog: 47190-10 (Lot serial: 005 1103812); Model Catalog: 47190-10 (Lot serial: 005 1011640); Model Catalog: 54030D (Lot serial: 005 1091906); Model Catalog: 54030D (Lot serial: 005 932215); Model Catalog: 54030D (Lot serial: 005 874256); Model Catalog: 47190-10 (Lot serial: 005 749777); Model Catalog: 54030D (Lot serial: 005 757723); Model Catalog: 47190-10 (Lot serial: 005 928442)
  • Product Description
    Invitrogen Cw High Res Unitray SSP Kits
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION