Events

Recall of Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge

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
    61629
  • Event Risk Class
    Class 2
  • Event Number
    Z-1540-2012
  • Event Initiated Date
    2012-04-02
  • Event Date Posted
    2012-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108560
  • 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
    Total,prostate specific antigen(noncomplexed&complexed) for detection of prostate cancer - Product Code MTF
  • Reason
    Siemens has confirmed a report of leaking flex(r) reagent cartridge lot 11300bb from dimension vista(r) tpsa; when a leaking flex(r) is used, patient test results may be falsely depressed.
  • Action
    Siemens sent an Urgent Field Safety Notification letter dated April 14, 2012 to all Dimension Vista(R) System customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and discard any remaining inventory of the affected product. Customers were asked to complete the attached form and fax it to 302-631-8467 to indicate that you have received the notification. For technical questions or concerns, contact the Siemens Technical Solutions Center at 800-441-9250.

Device

Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge
  • Model / Serial
    Catalog number: K6451; Mnemonic: TPSA; lot number 11300BB, exp 10/26/2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: AL, AZ, CA, CO, CT, FL IL, LA, MD, MI, MN, MS, MT, NC, NH, NJ, NV, NY, OH, PA, SD, TN, TX, UT, WI ,WV including Puerto Rico.
  • Product Description
    Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge || Product Usage: || The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) 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