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
    70949
  • Event Risk Class
    II
  • Event Initiated Date
    2014-09-04
  • 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
    On june 26 2014 one customer complaint was received for this issue (internal ref. # pr162312): a customer reported that a sample had discrepant results when using ssp unitray versus two other typing methods. ssp unitray typed the sample as dpb1*04:01dpb1*81:01. the correct assignment should be dpb1*04:01 dpb1*33:01. this is considered a mistype result.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 451616D (Lot serial: 009 1568516); Model Catalog: 451606D (Lot serial: 009 1568516); Model Catalog: 451606D (Lot serial: 008 1154360); Model Catalog: 451616D (Lot serial: 009 1464121); Model Catalog: 451606D (Lot serial: 009 1464121); Model Catalog: 451616D (Lot serial: 009 1415057); Model Catalog: 451606D (Lot serial: 009 1415057); Model Catalog: 451616D (Lot serial: 008 1289713); Model Catalog: 451606D (Lot serial: 008 1289713); Model Catalog: 451616D (Lot serial: 008 1220578); Model Catalog: 451606D (Lot serial: 008 1220578); Model Catalog: 451616D (Lot serial: 008 1190373); Model Catalog: 451606D (Lot serial: 008 1190373); Model Catalog: 451616D (Lot serial: 008 1154360); Model Catalog: 54070D (Lot serial: 009 1544263); Model Catalog: 54070D (Lot serial: 009 1450550); Model Catalog: 54070D (Lot serial: 008 1204422); Model Catalog: 54070D (Lot serial: 008 1256851); Model Catalog: 54070D (Lot serial: 009 1377591)
  • Product Description
    DPB1 SSP UNITRAY 12 TESTS DPB1 SSP UNITRAY W/TAQ 12 TEST
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION