Events

Recall of Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Reagent Cartridge (K4071)

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
    62835
  • Event Risk Class
    Class 2
  • Event Number
    Z-0408-2013
  • Event Initiated Date
    2012-08-09
  • Event Date Posted
    2012-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111837
  • 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
    Enzyme immunoassay theophylline - Product Code KLS
  • Reason
    Firm has received complaints from customers of "abnormal reaction" errors occurring on calibrations, qc and patient samples. the abnormal reaction flag is being triggered by an internal check in the method for atypical particle reagent aggregation.
  • Action
    Siemens Healthcare Diagnostic sent a Urgent Field Safety notice dated July, 20. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please immediately discontinue use and discard any remaining inventory of Dimension Vista¿ Theophylline Flex¿ reagent cartridge (THEO, Catalog # K4071) lot 12135AE and/or 12171BB. Please complete the attached form and fax it to (302)631-8467 to indicate that you have received this information and to facilitate your additional no charge replacement. We ask that you forward this notification to anyone to whom you may have distributed this lot. If you have technical questions or concerns, please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance. For questions concerning the status of your no charge replacement order please contact your Siemens Customer Service Center at 888-588-3916. We apologize for the inconvenience that this situation has caused. Thank you for your patience and continued support.

Device

Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Reagent Cartridge (K4071)
  • Model / Serial
    Lots 12135AE and 12171BB
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) including the states of AL, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, VT, WA and WI.
  • Product Description
    Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) || The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system.
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc.

Manufacturer

Siemens Healthcare Diagnostics, Inc.
  • Manufacturer Address
    Siemens Healthcare Diagnostics, Inc., 500 GBC Drive, Mailstop 514, PO BOX 6101, Newark DE 19714-6101
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA