Events

Recall of QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cellestis 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
    64228
  • Event Risk Class
    Class 2
  • Event Number
    Z-0889-2013
  • Event Date Posted
    2013-02-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115630
  • 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
    Cellestis is recalling quantiferon¿¿ - tb gold tb blood collection tubes and ha tb blood collection tubes due to potential contamination.
  • Action
    Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON¿" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.

Device

QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes
  • Model / Serial
    Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Ireland, Israel, Jordan, Luxembourg, Mexico, Netherlands, New Zealand, Peru, Poland, Saudi Arabia, Slovakia, Slovenia, South Africa, Switzerland, and Turkey.
  • Product Description
    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. || Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood.
  • Manufacturer
    Cellestis Inc

Manufacturer

Cellestis Inc
  • Manufacturer Address
    Cellestis Inc, 28358 Constellation Rd Ste 698, Santa Clarita CA 91355-5044
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA