inforMED
MalfunctionGRT

TB QUANTIFERON GOLD

Received Feb 24, 2009 · Event occurred Feb 2, 2009

Report MW5010078 · MDR key 1327250

Device

Generic name

None

Product problems

  • False Positive Result

Patient

26 YR

  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

TB QUANITFERON TEST REPORTED POSITIVE ON THE ABOVE DATE. DUE TO INCREASE IN THE NUMBER OF FALSE POSITIVES WITH THIS TEST THROUGH QUEST DIAGNOSTICS, IT WAS REPEATED IN 2009 AND WAS REPORTED UNLIKELY ON THE SECOND TEST. DIAGNOSIS OR REASON FOR USE: INFECTION.