QuantiFERON®-TB Gold Plus 1Recalls & reported problems
Qiagen Sciences Inc. · QFT-Plus 2 Plate Elisa Kit · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04053228015864), received between Apr 18, 2024 and Apr 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (P010033); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGED FALSE POSITIVE WITH QUANTIFERON TB PLUS ELISA, LEADING TO UNNECESSARY TREATMENT AND SERIOUS MEDICAL CONSEQUENCE.
Patient problems: Unspecified Infection
MAUDE report 19132630 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010033. One submission often covers many models, so check the product and lot details in each record.
- Z-1230-2016 · Feb 2, 2016 · TerminatedQFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
- Z-0889-2013 · Sep 27, 2012 · TerminatedVacuette Cellestis 1 ml QuantiFERON TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON-TB
- Z-0888-2013 · Sep 27, 2012 · TerminatedVACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnos
Other Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis devices
- QuantiFERON-TB Gold 2 Plate Kit 1Qiagen Sciences Inc. · Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis9 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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