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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

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

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.