Devices

Device Recall QuantiFERON TBGold

Model / Serial
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
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
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.
Product Description
QFT TB Antigen Tube. || QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Manufacturer
Qiagen Sciences LLC
1 Event
- Recall of Device Recall QuantiFERON TBGold

Manufacturer

Qiagen Sciences LLC

Manufacturer Address
Qiagen Sciences LLC, 19300 Germantown Rd, Germantown MD 20874-1415
Manufacturer Parent Company (2017)
QIAGEN N.V.
Source
USFDA

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