Events

Recall of DIMENSION CLINICAL CHEMISTRY SYS. - AUTOMATED HDL CHOLESTEROL (AHDL) 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
    73305
  • Event Risk Class
    III
  • Event Initiated Date
    2014-07-10
  • 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 received five customer complaints on incorrect instructions for use (ifu) found in some cartons of the dimension ahdl flex reagent cartridge lot ga5069. the dimension aldl idu was found instead.

Device

DIMENSION CLINICAL CHEMISTRY SYS. - AUTOMATED HDL CHOLESTEROL (AHDL) ASSAY
  • Model / Serial
    Model Catalog: DF48B (Lot serial: GA5069)
  • Product Description
    Dimension Clinical Chemistry System - Automated HDL Chloesterol (AHDL) Assay
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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