Events

Recall of ACTIN FSL ACTIVATED PTT REAGENT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE 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
    20599
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-15
  • 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
    When the reagent is used to monitor the effectiveness of unfractionated heparin therapy or oral anticoagulants there may be an erroneous drift of results with a higher than the clincally acceptable limits of heparin samples. the increased heparin sensitivity may lead to longer activated partial thromboplastin times (aptt) leading to inappropriately decreasing anticoagulant dosage. inappropriate reduction of anticoagulation increase the risk of thromboembolism.

Device

ACTIN FSL ACTIVATED PTT REAGENT
  • Model / Serial
    Model Catalog: B4219-2 (Lot serial: 537374); Model Catalog: B4219-1 (Lot serial: 537374); Model Catalog: B4219-2 (Lot serial: 537366); Model Catalog: B4219-1 (Lot serial: 537366); Model Catalog: B4219-2 (Lot serial: 537365A); Model Catalog: B4219-1 (Lot serial: 537365A); Model Catalog: B4219-2 (Lot serial: 537365); Model Catalog: B4219-1 (Lot serial: 537365); Model Catalog: B4219-2 (Lot serial: 537362A); Model Catalog: B4219-1 (Lot serial: 537362A); Model Catalog: B4219-2 (Lot serial: 537362); Model Catalog: B4219-1 (Lot serial: 537362); Model Catalog: B4219-2 (Lot serial: 537360A); Model Catalog: B4219-1 (Lot serial: 537360A); Model Catalog: B4219-2 (Lot serial: 537360); Model Catalog: B4219-1 (Lot serial: 537360); Model Catalog: B4219-1 (Lot serial: 537374A); Model Catalog: B4219-2 (Lot serial: 537374A); Model Catalog: B4219-1 (Lot serial: 547301); Model Catalog: B4219-2 (Lot serial: 547301); Model Catalog: B4219-1 (Lot serial: 547301A); Model Catalog: B4219-2 (Lot serial: 547301A); Model Catalog: B4219-2
  • Product Description
    DADE ACTIN FSL ACTIVATED PTT REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC