Events

Recall of SSP UNITRAY - HIGH RESOLUTION CLASS II

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
    44028
  • Event Risk Class
    III
  • Event Initiated Date
    2014-02-27
  • 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
    A labeling error was identified where a false negative lead to a mistype. specifically a primer mix (r15-05c) indicated a false negative for drb1*15:34/54/66 alleles. this results in a mistype of drb1*15:34 as drb1*16:01:02 and drb1*15:54/66 as drb1*15:25.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 450112D (Lot serial: 011 1049955 1314672); Model Catalog: 54290D (Lot serial: 001 769069); Model Catalog: 450112D (Lot serial: 010 743202 847129); Model Catalog: 450102D (Lot serial: 010 743202 847129); Model Catalog: 450112D (Lot serial: 010 743202 824730); Model Catalog: 450102D (Lot serial: 010 743202 824730); Model Catalog: 450112D (Lot serial: 010 743202 904081); Model Catalog: 450102D (Lot serial: 010 743202 904081); Model Catalog: 450112D (Lot serial: 010 743202 867121); Model Catalog: 450102D (Lot serial: 010 743202 867121); Model Catalog: 450112D (Lot serial: 010 743202 807163); Model Catalog: 450102D (Lot serial: 010 743202 807163); Model Catalog: 450112D (Lot serial: 0111274159); Model Catalog: 450102D (Lot serial: 0111274159); Model Catalog: 450112D (Lot serial: 011 872999); Model Catalog: 450102D (Lot serial: 011 872999); Model Catalog: 450112D (Lot serial: 011 1274159); Model Catalog: 450102D (Lot serial: 011 1274159); Model Catalog: 450112D (Lot serial: 011 1049955); Model Catal
  • Product Description
    SSP UNITRAY - HIGH RESOLUTION
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION