Z-0888-2013 Class II Terminated
FDA device recall Z-0888-2013 was initiated by Cellestis Inc on September 27, 2012 and is designated Class II. Reason for recall: Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. The recall status is terminated (terminated April 25, 2013). Affected quantity: 309,400 units.
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