Events

Recall of MICRO SSP HIGH RESOLUTION HLA CLASS II DNA TYPING TRAYS

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
    26870
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-22
  • 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 use of this product in combination with optional analysis software hla fusion software may cause misassignment to drb1*15:65 when positive reactivity is seen in well 11a. with the presence of drb4*01:03 and drb5*01:01 only a drb1*15:65 without drb1*15:01 typing result is suggested. this is due to a limitation in the software with cross loci wells. analysis of this product without hla fusion software will not generate incorrect suggested typing results.

Device

MICRO SSP HIGH RESOLUTION HLA CLASS II DNA TYPING TRAYS
  • Model / Serial
    Model Catalog: SSP2H (Lot serial: Lot 005 batches 003-034)
  • Product Description
    MICRO SSP HIGH RESOLUTION HLA CLASS II DNA TYPING TRAYS
  • Manufacturer
    ONE LAMBDA INC

Manufacturer

ONE LAMBDA INC