Events

Recall of ADVIA CHEMISTRY ENZYME 2 CALIBRATOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE DIAGNOSTICS 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
    82885
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-18
  • 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 healthcare diagnostics has confirmed a positive bias of up to 41% in quality control and patient results for aspartate aminotransferase (ast) and aspartate aminotransferase concentrated (ast_c) assays following calibration with advia chemistry enzyme 2 calibrator lots 6jd079 and 6md042. only aspartate aminotransferase (ast) and aspartate aminotransferase concentrated (ast_c) assays are affected. all other assays (alt alt_c altp5p altp_c astp5p and astp_c) using the advia chemistry enzyme 2 calibrator are not impacted.

Device

ADVIA CHEMISTRY ENZYME 2 CALIBRATOR
  • Model / Serial
    Model Catalog: 10916058 (Lot serial: 6MD042); Model Catalog: 10916058 (Lot serial: 6JD079)
  • Product Description
    ADVIA CHEMISTRY ENZYME 2 CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.
  • Manufacturer Address
    TARRYTOWN
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC