Events

Recall of SSP UNITRAY - LOW 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
    24968
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-21
  • 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
    During an internal complaint investigation for problem report pr#135598 the reactivity assignment in our human oligotyping software (hos) program for a32:04 allele in primer mix pm019e was determined to be incorrect. the catalog and lot numbers of the products listd above have been identified to be affected by the incorrect reactivity assignment. the kits would produce an incorrect low resolution typing or mistyping result of a*02 a*03 alleles when testing a sample which has the a32:04 allele. the user would be unaware of the incorrect type unless they confirm the sample typing by another method therefore this would be considered a mistype.

Device

SSP UNITRAY - LOW RESOLUTION CLASS I
  • Model / Serial
    Model Catalog: 78600-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78000-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78601-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 78001-10 (Lot serial: > 10 numbers contact mfg.); Model Catalog: 54340D (Lot serial: 038 1391657); Model Catalog: 54340D (Lot serial: 038 1360419); Model Catalog: 54340D (Lot serial: 038 1306788); Model Catalog: 54340D (Lot serial: 038 1249868); Model Catalog: 54310D (Lot serial: 022 1385981); Model Catalog: 54310D (Lot serial: 022 1256853); Model Catalog: 54360D (Lot serial: 029 1395129); Model Catalog: 54360D (Lot serial: 029 1247232); Model Catalog: 54360D (Lot serial: 029 1293558); Model Catalog: 54360D (Lot serial: 029 1306794); Model Catalog: 54360D (Lot serial: 029 1362561)
  • Product Description
    SSP UNITARY - LOW RESOLUTION CLASS I
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION