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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64228
Product Type Devices
Status Ongoing
Recalling Firm Cellestis Inc
City Santa Clarita
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-27
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013 Class II Cellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. 29,690 units Z-0889-2013
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. Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013 Class II Cellestis is recalling QuantiFERON® - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. 309,400 units Z-0888-2013
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