BEUDAMED
    FDA Enforcement Class II Terminated

    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,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.

    Recall: Z-0888-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0888-2013
    Event ID
    64228
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cellestis Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 6, 2013
    Initiation Date
    September 27, 2012
    Classification Date
    February 26, 2013
    Termination Date
    April 25, 2013
    Address
    28358 Constellation Rd Ste 698, N/A, Santa Clarita, CA, 91355-5044, United States

    Description

    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,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.

    Reason

    Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.

    Code Info

    Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013

    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.

    Quantity

    309,400 units