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
    26285
  • Event Risk Class
    III
  • Event Initiated Date
    2010-03-02
  • 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
    Lane 27 (r04-28a) in the drb1*04 ssp unitray kit lots and batches mentioned was found to produce a false positive band in the correct base pair size. this will affect typing results on samples that are drb1*0401 homozygotes since they could be erroneously reported as drb1*0426.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 45040-4 (Lot serial: 010/529773); Model Catalog: 45041-4 (Lot serial: 010/576600); Model Catalog: 45040-4 (Lot serial: 010/576600); Model Catalog: 45041-4 (Lot serial: 010/712450); Model Catalog: 45040-4 (Lot serial: 010/712450); Model Catalog: 45041-4 (Lot serial: 010/706704); Model Catalog: 45040-4 (Lot serial: 010/706704); Model Catalog: 45041-4 (Lot serial: 010/670484); Model Catalog: 45040-4 (Lot serial: 010/670484); Model Catalog: 45041-4 (Lot serial: 010/660310); Model Catalog: 45040-4 (Lot serial: 010/660310); Model Catalog: 45041-4 (Lot serial: 010/650982); Model Catalog: 45040-4 (Lot serial: 010/650982); Model Catalog: 45041-4 (Lot serial: 010/617620); Model Catalog: 45040-4 (Lot serial: 010/617620); Model Catalog: 45041-4 (Lot serial: 010/529773)
  • Product Description
    DRB1*04 SSP UNITRAY
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION