FDA Device recall Z-1230-2016
QFT TB Antigen Tube
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of QFT TB Antigen Tube by Qiagen Sciences, citing potential for obtaining a false positive result due to the possibility of endotoxin presence.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1230-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-02 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Qiagen Sciences |
| Distribution | GA |
Product
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Reason
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
Identifiers
| code_info | CODE(S): a. Cat # 0592-0201 Lot #A150135A TB Antigen Tube Expiry: April 2016 b. Cat # 0590-0201 Lot #0590612…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1230-2016%22
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