Events

Recall of Siemens Dimension Vista CHEM 1 CAL

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
    69063
  • Event Risk Class
    Class 2
  • Event Number
    Z-2720-2014
  • Event Initiated Date
    2014-08-18
  • Event Date Posted
    2014-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129484
  • 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, multi-analyte mixture - Product Code JIX
  • Reason
    Siemens healthcare diagnostics has received complaints for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista® chem 1 cal, lot 3gm081. investigation by siemens confirms that qc and patient samples under-recovers mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.
  • Action
    Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative.

Device

Siemens Dimension Vista CHEM 1 CAL
  • Model / Serial
    lot 3GM081, exp. 07-01-2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) and Internationally to Australia Austria Belgium Canada Czech Republic Finland France Germany Great Britain Italy Japan Netherlands New Zealand Norway Portugal Slovak Republic Slovenia South Korea Spain Switzerland
  • Product Description
    Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. || The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista¿ System.
  • 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