Home / Recalls / Cellestis Inc / Z-0888-2013

Z-0888-2013 Class II Terminated

Recalled by Cellestis Inc — Santa Clarita, CA

Recall Details

Product Type: Devices
Report Date: March 6, 2013
Initiation Date: September 27, 2012
Termination Date: April 25, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 309,400 units

Product 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 for Recall

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

Distribution Pattern

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.

Code Information

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