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
    31759
  • Event Risk Class
    III
  • Event Initiated Date
    2012-06-06
  • 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
    Internal investigation identified a trend of three complaints regarding lanes 27 and 39 giving false negative results for a dpb1*126:01 allele. the primer mixes within lanes 27 and 39 target regions of the dpb1*126:01 allele which are undefined. currently there are qc comments provided with the kit about the primers in the affected lanes stating that they have predicted reactivity. the dpb1*126:01 allele reactivity is assigned according to the common alleles. the primer mixes have not been tested with a dpb1*126:01 sample the labeling stated the primers in lanes 27 and 39 would amplify the targeted sequences in the dpb1*126:01 allele.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 451606D (Lot serial: > 10 contact manufacturer); Model Catalog: 451616D (Lot serial: > 10 contact manufacturer)
  • Product Description
    DPB1 SSP UniTray Kit/DPB1 SSP UniTray Kit with Taq Polymerase
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION