Events

Recall of SIMPLIRED D-DIMER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BBI SOLUTIONS OEM LIMITED.

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
    46272
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-31
  • 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
    Data from long term stability monitoring shows that there is a decline in sensitivity performance of the simplired d-dimer kits containing test reagent 1012-34437. this decline in sensitivity performance may affect qualitative results. false negative results are possible on the simplired d-dimer test which may incorrectly influence the clinical diagnostic decision and could in some circumstances contribute to a delay in the diagnosis of deep vein thrombosis (dvt) or pulmonary embolism (pe).

Device

SIMPLIRED D-DIMER
  • Model / Serial
    Model Catalog: DSRK4 (Lot serial: PW070A)
  • Product Description
    SIMPLIRED D-DIMER
  • Manufacturer
    BBI SOLUTIONS OEM LIMITED

Manufacturer

BBI SOLUTIONS OEM LIMITED