Events

Recall of Device Recall ADVIA Chemistry Enzyme 2 Calibrator

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    76695
  • Event Risk Class
    Class 3
  • Event Number
    Z-1712-2017
  • Event Initiated Date
    2017-02-23
  • Event Date Posted
    2017-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153922
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calibrator, primary - Product Code JIS
  • 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.
  • Action
    Siemens mailed an Urgent Medical Device Correction Notice to affected customers on 02/21/2017. The notice informed calibrator customers of the reason for the correction, risk to health, and actions to be taken by customers who are in the process of converting from the fixed factor to the enzyme calibrated assay and information for customers who had already converted, until the investigation is complete.

Device

Device Recall ADVIA Chemistry Enzyme 2 Calibrator
  • Model / Serial
    Lots 6JD079 and 6MD042
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - United States Nationwide: Denmark Sweden Norway Great Britain Belgium Netherlands Spain Israel Switzerland France Portugal Greece Germany Slovenia Czech Republic Hong Kong Colombia Korea Australia
  • Product Description
    ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture || Product Usage: || Assays included in Enzyme 2 Calibrator: AST, AST_c ALT, ALT_c, ALTP5P, ALTP_c, ASTP5P and ASTP_c
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA