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
    61343
  • Event Risk Class
    III
  • Event Initiated Date
    2014-03-12
  • 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
    When using 54340d allset+ gold hla abc low res kit lot 038 1249868 primer mix pm085c has been shown to produce a weak false positive reaction of correct size (420 base pair pcr amplicon) in the presence of samples containing c*04 homozygote allele(s). primer mix pm085c can be found in lane 78. as a result of the false positive reaction samples containing two c*04 alleles could produce a mistype or no-type result depending on the reaction pattern corresponding to the full abc hla typing.

Device

ALLSET GOLD ABC LOW RESOLUTION KIT
  • Model / Serial
    Model Catalog: 54340D (Lot serial: 038 1249868)
  • Product Description
    AllSet+T Gold HLA ABC Low Res
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION