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
    28665
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-12
  • 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
    This field safety notice serves to inform customers of a change in primer reactivity: 1) primer b-110a in the listed b high res unitrays does not amplify b*1335 b*1535 and b*9541 alleles and 2) primer b54-o4a in the listed b22 unitrays does not amplify b*390601 and b*3928 alleles.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 47300-10 (Lot serial: 004/46487); Model Catalog: 47300-10 (Lot serial: 004/642261); Model Catalog: 47300-10 (Lot serial: 008/685133); Model Catalog: 47250-3 (Lot serial: 008/685133); Model Catalog: 47300-10 (Lot serial: 008/656154); Model Catalog: 47250-3 (Lot serial: 008/656154); Model Catalog: 47300-10 (Lot serial: 008/614659); Model Catalog: 47250-3 (Lot serial: 008/614659); Model Catalog: 47300-10 (Lot serial: 008/709385); Model Catalog: 47250-3 (Lot serial: 008/709385); Model Catalog: 47300-10 (Lot serial: 008/529771); Model Catalog: 47250-3 (Lot serial: 008/529771); Model Catalog: 47300-10 (Lot serial: 008/49110); Model Catalog: 47250-3 (Lot serial: 008/49110); Model Catalog: 47250-3 (Lot serial: 004/642261); Model Catalog: 47250-3 (Lot serial: 004/46487)
  • Product Description
    B HIGH RES UNITRAY B22 SSP UNITRAY
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION