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 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
    17645
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-29
  • 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
    Internal investigation has confirmed that primer mix b-086 found on lane 83 in the b high resolution allset gold and ssp unitray kits and on lane 9 of the b17 ssp unitray and allset gold kits gives a false negative for the b*47:03 allele according to the labeling. however the primer mix b-086 is functioning as originally designed. the b*47:03 allele has a mismatch in the primer's targeted sequence and sample specific functionality could not be confirmed through testing due to lack of sample availability.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 47230-3 (Lot serial: 009 984375); Model Catalog: 47300-10 (Lot serial: 009 984375); Model Catalog: 47230-3 (Lot serial: 010 1103786); Model Catalog: 47300-10 (Lot serial: 010 1103786); Model Catalog: 47230-3 (Lot serial: 004 743203); Model Catalog: 47300-10 (Lot serial: 004 743203); Model Catalog: 47230-3 (Lot serial: 008 709385); Model Catalog: 47300-10 (Lot serial: 008 709385); Model Catalog: 47230-3 (Lot serial: 008 757730); Model Catalog: 47300-10 (Lot serial: 008 757730); Model Catalog: 47230-3 (Lot serial: 008 800850); Model Catalog: 47300-10 (Lot serial: 008 800850); Model Catalog: 47230-3 (Lot serial: 008 839301); Model Catalog: 47300-10 (Lot serial: 008 839301); Model Catalog: 47230-3 (Lot serial: 008 873000); Model Catalog: 47300-10 (Lot serial: 008 873000); Model Catalog: 54020D (Lot serial: 009 979631); Model Catalog: 47230-3 (Lot serial: 009 910766); Model Catalog: 47300-10 (Lot serial: 009 910766)
  • Product Description
    B17 SSP UniTray Kit/B Locus High Res SSP UniTray Kit
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION