QFT TB Antigen Tube — Class II medical device recall Z-1230-2016
Terminated recall by Qiagen Sciences LLC, reported 2016-03-30, distributed in GA. Potential for obtaining a false positive result due to the possibility of endotoxin presence.
| Recall number | Z-1230-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2016-02-02 |
| Classified | 2016-03-22 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2016-08-16 |
| Distributed | GA |
| Countries outside the US | AT, BE, CH, CZ, DE, DK, EE, ES, FR, GB, IE, KR, LU, NL, PL, PT, QA, SG, TR, ZA |
| Quantity | 152,900 tubes |
| Reason classes | sterility |
| Lot numbers | 059061291, 059087361, 0597-0201, 0597-0701, 059772271SPP, 059772281, 200PK, 622686, A150135ATB |
| Model numbers | 0590-0201, 0592-0201, 0597-0201, 0597-0701, 622686 |
| Expiration dates | 2016-04-20 |
Product
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Reason for recall
Potential for obtaining a false positive result due to the possibility of endotoxin presence.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1230-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.