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
    144102
  • Event Risk Class
    III
  • Event Initiated Date
    2010-03-04
  • 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
    Primer mix pm169a contained in the named kits may produce a weak true positive band at the correct base pair size of 135bp. the primer mix is designed to detect b*15 alleles. the problem of a weak true positive signal could mean that a test would have to be repeated.

Device

SSP UNITRAY - LOW RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 78700-10 (Lot serial: 025 663049); Model Catalog: 78001-10 (Lot serial: 025 663049); Model Catalog: 78000-10 (Lot serial: 025 663049); Model Catalog: 78700-10 (Lot serial: 036 656155); Model Catalog: 78001-10 (Lot serial: 036 656155); Model Catalog: 78000-10 (Lot serial: 036 656155); Model Catalog: 78000-10 (Lot serial: 036 616504); Model Catalog: 78700-10 (Lot serial: 036 616504); Model Catalog: 78001-10 (Lot serial: 036 616504); Model Catalog: 78100-10 (Lot serial: 034 625679)
  • Product Description
    ABC SSP UNITRAY AND B LOCUS SSP UNITRAY
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION