Events

Recall of SSP UNITRAY - LOW 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
    58090
  • Event Risk Class
    III
  • Event Initiated Date
    2011-01-18
  • 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 taq polymerase is not amplifying dna as intended. there is suspected contamination that is causing the taq to not work properly. kits which contain the affected lot of taq (taq polymerase vial lot # 864459) are not useable unless a different lot of taq is used.

Device

SSP UNITRAY - LOW RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 78001-10 (Lot serial: 037 851612/883129)
  • Product Description
    INVITROGEN ABC UNITRAY WITH TAQ
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION