Events

Recall of STRATUS CS ACUTE CARE SYS - CARDIOPHASE HIGH SENSITIVITY CRP (CCRP) ASSAY

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
    94244
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-24
  • 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
    Siemens has confirmed that some stratus cs acute care ccrp testpaks in named lots may generate slope errors which result in a failed calibration for the hscrp assay. as a result patient and quality control results cannot be generated.

Device

STRATUS CS ACUTE CARE SYS - CARDIOPHASE HIGH SENSITIVITY CRP (CCRP) ASSAY
  • Model / Serial
    Model Catalog: CCCRP (Lot serial: 426130002); Model Catalog: CCCRP (Lot serial: 426214002)
  • Product Description
    STRATUS CS ACUTE CARE CCRP TESTPAK
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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