QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
- Company
- Qiagen Sciences Llc
- Recall Initiated
- February 2, 2016
- Terminated
- August 16, 2016
- Recall Number
- Z-1230-2016
- Quantity
- The total amount of product distributed 152,900 Tubes
- Firm Location
- Germantown, MD
Reason for Recall
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
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.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.