Events

Recall of Device Recall Dimension Total Prostate Specific Antigen Flex 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
    47518
  • Event Risk Class
    Class 2
  • Event Number
    Z-1606-2008
  • Event Initiated Date
    2008-03-24
  • Event Date Posted
    2008-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69659
  • 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 - Product Code MTF
  • Reason
    False results: the product may exhibit falsely elevated results. the affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of quality control.
  • Action
    The recalling firm issued a letter (Urgent Field Safety Notice) dated 3/25/08 to inform their customers to discontinue use of any remaining inventory, retest using an alternate lot for those samples from post-prostatectomy patients which recovered positive TPSA results less than 1.0 ng/nL. The firm has requested that you call the them for no-charge replacement product at 1-800-441-9250 and/or for technical assistance.

Device

Device Recall Dimension Total Prostate Specific Antigen Flex Reagent Cartridge
  • Model / Serial
    Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    The product was shipped to medical facilities nationwide. The product was also shipped to Germany, Singapore, Canada, Japan and AE
  • Product Description
    Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE 19714
  • Manufacturer
    Siemens Healthcare Diagnostics Inc.

Manufacturer

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