Events

Recall of ALLSET GOLD ABDRQ 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
    31128
  • Event Risk Class
    II
  • Event Initiated Date
    2012-03-19
  • 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
    Abc unitray ssp kits have a false negative in lane 13. internal investigation confirmed by sequence based typing that the customer had a sample type with a a*32:04 allele. therefore lane 13 has a confirmed false negative in the affected kits. however the primer mix in lane 13 is functioning as designed. the a*32:04 allele has an undefined sequence region which had not been confirmed through testing. the worksheet is incorrect in listing this allele as positive for lane 13.

Device

ALLSET GOLD ABDRQ LOW RESOLUTION KIT
  • Model / Serial
    Model Catalog: 54360D (Lot serial: 028 984379); Model Catalog: 54340D (Lot serial: 037 791458); Model Catalog: 54340D (Lot serial: 037 1099919); Model Catalog: 78100-10 (Lot serial: 035 757737); Model Catalog: 78100-10 (Lot serial: 035 709363); Model Catalog: 78100-10 (Lot serial: 035 841438); Model Catalog: 78100-10 (Lot serial: 035 1091909); Model Catalog: 78000-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78601-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78600-10 (Lot serial: > 10 contact manufacturer); Model Catalog: 78001-10 (Lot serial: > 10 contact manufacturer)
  • Product Description
    Invitrogen AllSet Gold SSP HLA ABDRDQ Low Res Kits
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION