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U.S. Department of Health and Human Services

Class 2 Device Recall QuantiFERON TBGold

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  Class 2 Device Recall QuantiFERON TBGold see related information
Date Initiated by Firm February 02, 2016
Create Date March 22, 2016
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-1230-2016
Recall Event ID 73384
PMA Number P010033 
Product Classification Test, immunity, cell mediated, mycobacterium tuberculosis - Product Code NCD
Product QFT TB Antigen Tube.

QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Code Information CODE(S):   a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016  b. Cat # 0590-0201 Lot #059061291 TB-Nil 200pk Expiry: April 2016  c. Cat # 0597-0201 Lot #059772271 SPP Expiry: April 2016  d. Cat # 0597-0701 Lot #059772281 SPP-Luer Expiry: April 2016  e. Cat # 622686 Lot #059087361 TB-Nil 200 PK Expiry: April 2016 
Recalling Firm/
Qiagen Sciences LLC
19300 Germantown Rd
Germantown MD 20874-1415
For Additional Information Contact Donna Sowers
Manufacturer Reason
for Recall
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
FDA Determined
Cause 2
Nonconforming Material/Component
Action QIAGEN sent an "Urgent - Notification of Market Withdrawal" dated February 2, 2016, to all affected customers. The letter identify the product the problem and the action needed to be taken by the customer. Immediately discontinue use of this lot and discard any remaining inventory. Please acknowledge receipt of this notification and actions taken by completing the information on the next page, and return to: TechService-NA@qiagen.com or fax +1-661-775-7479. QIAGEN apologizes for any inconvenience this market withdrawal has caused, and continues to take every effort possible to ensure the highest quality of product is always available to our valued customers around the globe. Please do not hesitate to contact your local QuantiFERON sales representative or customer service representative should you have any questions or concerns. For further questions, please call ( 240) 686-7500.
Quantity in Commerce The total amount of product distributed 152,900 Tubes
Distribution Worldwide Distribution - US Distribution to the state of : Georgia., and to the countries of : Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, Great Britain, Ireland, Korea (South) Luxembourg, Netherlands, Poland, Portugal, Qatar, Russian (Federation), Singapore, Turkey and South Africa.
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