FDA Medical Device Recalls (openFDA)
Qiagen Sciences LLC: QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
- Recall number
- Z-1230-2016
- Recalling firm
- Qiagen Sciences LLC
- Product
- QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
- Status
- Terminated
- Initiated
- 2016-02-02
- Posted
- not on file
- Terminated
- 2016-08-16
- Reason
- Potential for obtaining a false positive result due to the possibility of endotoxin presence.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P010033"]
- Product code
- NCD
- Firm FEI
- 3003572099
- Firm city
- Germantown
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28