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 ONE LAMBDA INC.

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
    48563
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-18
  • 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
    A false negative reaction may be observed in the presence of a*11:01:04 specifially for primers pm118c pm118f a11-01 and a11-01a. this could lead to mis-typings during analysis.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 47291-10 (Lot serial: Lot 12 Batch 1306793); Model Catalog: 47290-10 (Lot serial: Lot 12 Batch 1306793); Model Catalog: 47081-2 (Lot serial: Lot 12 Batch 1306793); Model Catalog: 47080-2 (Lot serial: Lot 12 Batch 1306793); Model Catalog: 47291-10 (Lot serial: Lot 12 Batch 1467113); Model Catalog: 47290-10 (Lot serial: Lot 12 Batch 1467113); Model Catalog: 47081-2 (Lot serial: Lot 12 Batch 1467113); Model Catalog: 47080-2 (Lot serial: Lot 12 Batch 1467113); Model Catalog: 47291-10 (Lot serial: Lot 12 Batch 1580702); Model Catalog: 47290-10 (Lot serial: Lot 12 Batch 1580702); Model Catalog: 47081-2 (Lot serial: Lot 12 Batch 1580702); Model Catalog: 47080-2 (Lot serial: Lot 12 Batch 1580702); Model Catalog: 47291-10 (Lot serial: Lot 12 Batch 1608873); Model Catalog: 47290-10 (Lot serial: Lot 12 Batch 1608873); Model Catalog: 47081-2 (Lot serial: Lot 12 Batch 1608873); Model Catalog: 47080-2 (Lot serial: Lot 12 Batch 1608873); Model Catalog: 47291-10 (Lot serial: Lot 8 Batch 1221254); Model Catalo
  • Product Description
    SSP Unitray - High Resolution Class I;SSP Unitray - Low Resolution Combination (Class I);SSP Unitray - Low Resolution Class I
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC