Events

Recall of Device Recall Dimension Vista(R) VANC 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
    62609
  • Event Risk Class
    Class 3
  • Event Number
    Z-2175-2012
  • Event Initiated Date
    2012-07-17
  • Event Date Posted
    2012-08-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111137
  • 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
    Radioimmunoassay, vancomycin - Product Code LEH
  • Reason
    Siemens has received complaints of customers experiencing slopes >1.05 when calibrating flex(r) reagent cartridge lot 12095ad. this results in a slope failure and prevents the vanc assay from being run on the dimension vista(r) system.
  • Action
    The firm initiated their recall of this product on July 17, 2012 by sending an Urgent Field Safety Notification via FedEx next day delivery to all consignees. The Notice informed consignees of the high calibration slopes with the affected device. Affected consignees were requested to immediately discontinue use and discard any remaining Dimension Vista(R) VANC Flex(R) reagent cartridges, lot 12095AD. Affected customers were provided with replacement cartridges. Customers were to also complete the attached form and fax it back to the number provided. The notification letter should be forwarded to anyone, whom customers may have further distributed the affected lot. Questions and concerns should be directed to Siemens Technical Solutions Center at 800-441-9250.

Device

Device Recall Dimension Vista(R) VANC Flex(R) Reagent Cartridge
  • Model / Serial
    lot 12095AD, exp 2013-04-04
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, including Washington, DC and the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV, and the countries of Canada, New Zealand, Germany, and Puerto Rico.
  • Product Description
    Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). || For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista 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