Device product
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Z-1230-2016
Product summary
- Event
- Event 73384
- Status
- Terminated
- Classification
- Class II
- Quantity
- The total amount of product distributed 152,900 Tubes
- Official record key
device-enforcement:Z-1230-2016
Official wording
Reason: Potential for obtaining a false positive result due to the possibility of endotoxin presence.
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
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for obtaining a false positive result due to the possibility of endotoxin presence.