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U.S. Department of Health and Human Services

Class 2 Device Recall QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes

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 Class 2 Recall
QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on April 25, 2013
Recall Number Z-0888-2013
Recall Event ID 64228
Premarket Approval
PMA Number
P010033
Product Classification Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis - Product Code NCD
Product 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.
Code Information Cat # 0592-0201; Lot A111103N Exp 28 FEB, 2013
Recalling Firm/
Manufacturer
Cellestis Inc
28358 Constellation Rd Ste 698
Santa Clarita, California 91355-5044
For Additional Information Contact Kevin Liddle, PhD
661-775-7480
Manufacturer Reason
for Recall
Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Material/Component Contamination
Action Cellestis, inc., sent a "Notification of market withdrawal of QuantiFERON®" letter dated September 27, 2012 to its domestic and international customers. The letter described the product, problem and actions to be taken. The customers were informed to discontinue use of these products and any product sequestered such that it cannot be used or distributed. Cellestis will provide replacement materials, if and when a retest is required. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative at +613 8527 3500 or 661-775-7480 should you have any questions or concerns.
Quantity in Commerce 309,400 units
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NCD and Applicant = CELLESTIS INC
PMAs with Product Code = NCD and Applicant = CELLESTIS LIMITED
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