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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 Device Recall QuantiFERON TB Gold TB High Altitude (HA)Blood Collection Tubes see related information
Date Initiated by Firm September 27, 2012
Date Posted February 26, 2013
Recall Status1 Terminated 3 on April 25, 2013
Recall Number Z-0889-2013
Recall Event ID 64228
PMA Number P010033 
Product Classification Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
Product 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.
Code Information Cat # 0592-0501; Lot A111103M; Exp 28 FEB, 2013
Recalling Firm/
Manufacturer		 Cellestis Inc
28358 Constellation Rd Ste 698
Santa Clarita CA 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		 Process design
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 29,690 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NCD and Original Applicant = QIAGEN
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