Events

Recall of ALLSET GOLD ABC LOW RESOLUTION KIT

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
    94329
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-08
  • 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
    One complaint has been received. drb1 high res ssp unitray kits have a false negative in lane 44 for drb1*04:33 allele. internal investigation confirmed by sequence based typing that the customer had a drb1*04:33 allele. therefore lane 44 has a confirmed false negative in the affected kits according to the labeling. however the primer mix in lane 44 is functioning as originally designed. the drb1*04:33 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing.

Device

ALLSET GOLD ABC LOW RESOLUTION KIT
  • Model / Serial
    Model Catalog: 54340D (Lot serial: 017 904113); Model Catalog: 54340D (Lot serial: 017 1001675); Model Catalog: 54340D (Lot serial: 017 845070); Model Catalog: 45150-10 (Lot serial: 017 944896); Model Catalog: 45150-10 (Lot serial: 017 1103807)
  • Product Description
    AllSet Gold SSP HLA-DRB1 High Res Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION