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
    23933
  • Event Risk Class
    III
  • Event Initiated Date
    2015-04-17
  • 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
    One complaint regarding this issue has been received. one customer complaint (pr184220) was recorded. a customer reported that the reactivity for lanes 13 27 30 39 and 40 was negative for the dpb1*99:01 allele when the labeling of the dpb1 ssp unitray 12 tests kit (451606d) indicates the reactivity should be positive. the labeling discrepancy may lead to potentially mistyping a dpb1*99:01 allele (population frequency < 0.01%) as a dpb1*39:01 allele. after investigation it was determined that the dpb1 ssp unitray with taq 12 tests kit (451616d) and the allset gold dpb1 high res ssp kit (54070d) are also affected by the labeling issue since they contain the same primer present in the dpb1 ssp unitray 12 tests kit (451606d). life technologies confirmed the issue on 11 march 2015.

Device

SSP UNITRAY - HIGH RESOLUTION CLASS II
  • Model / Serial
    Model Catalog: 451606D (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 451616D (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 54070D (Lot serial: 009 1450550); Model Catalog: 54070D (Lot serial: 009 1544263); Model Catalog: 54070D (Lot serial: 009 1608835); Model Catalog: 54070D (Lot serial: 009 1377591); Model Catalog: 54070D (Lot serial: 009 1618548)
  • Product Description
    DPB1 SSP UNITRAY W/TAQ 12 TEST DPB1 SSP UNITRAY 12 TESTS
  • Manufacturer
    LIFE TECHNOLOGIES CORPORATION

Manufacturer

LIFE TECHNOLOGIES CORPORATION