Events

Recall of Device Recall QuantiFERON TBGold

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Qiagen Sciences LLC.

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
    73384
  • Event Risk Class
    Class 2
  • Event Number
    Z-1230-2016
  • Event Initiated Date
    2016-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143995
  • 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
    Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
  • Reason
    Potential for obtaining a false positive result due to the possibility of endotoxin presence.
  • Action
    QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.

Device

Device Recall QuantiFERON TBGold
  • Model / Serial
    CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
  • Product Description
    QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
  • Manufacturer
    Qiagen Sciences LLC

Manufacturer

Qiagen Sciences LLC
  • Manufacturer Address
    Qiagen Sciences LLC, 19300 Germantown Rd, Germantown MD 20874-1415
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA