inforMED
MalfunctionNCD

QUANTIFERON®-TB GOLD PLUS

Received Oct 27, 2025 · Event occurred Oct 1, 2025

Report 23389720 · MDR key 23389720

Device

Generic name

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Model number

1

Catalog number

622433

Lot number

58105304

Product problems

  • Failure to Obtain Sample

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PATIENT HAD BLOOD DRAW FOR TB [TUBERCULOSIS] GOLD-QUANTIFERON LABS. NURSES WERE AWARE TO TAKE FULL TUBES FOR SAMPLE. SAMPLE WAS TAKEN TO LABORATORY, AND AFTER 2 DAYS THE LABORATORY DETERMINED THERE WAS NOT ENOUGH AMOUNT TO PROCESS THE SAMPLE. SECOND SAMPLE FROM SAME LOT HAD SAME RESULT, FAILURE TO FILL USING STANDARD "BUTTERFLY" NEEDLE SET. MANUFACTURER RESPONSE FOR BLOOD COLLECTION TUBES, QUANTIFERON - TB GOLD PLUS (QFT - PLUS) (PER SITE REPORTER). NOTIFIED VIA EMAIL ON [REDACTED].