Events

Recall of STRATUS CARDIAC TROPONIN I

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DADE INTERNATIONAL INC..

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
    24540
  • Event Risk Class
    III
  • Event Initiated Date
    1999-05-28
  • 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
    These lots may exhibit non-specific interference in some normal human samples and in some healthy individuals may exceed the normal laboratory range.

Device

STRATUS CARDIAC TROPONIN I
  • Model / Serial
    Model Catalog: B5700-64 (Lot serial: 1215 KXTN-1219); Model Catalog: B5700-64 (Lot serial: KXTN-1206 THRU KXTN-1210); Model Catalog: B5700-64 (Lot serial: KXTN-1146 THRU KXTN-1204); Model Catalog: B5700-64 (Lot serial: KXTN-1212 KXTN-1214 KXTN-)
  • Product Description
    STRATUS CARDIAC TROPONIN I
  • Manufacturer
    DADE INTERNATIONAL INC.

Manufacturer

DADE INTERNATIONAL INC.
  • Manufacturer Address
    MIAMI
  • Source
    HC