QuantiFERON-TB Gold 2 Plate Kit 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04053228002109), received between Feb 3, 2016 and Feb 3, 2016 — classified as 9 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (8 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CUSTOMER COMPLAINT RECEIVED FROM (B)(6) REPORTING AN INCREASE IN THE RATE OF POSITIVES AND GREY ZONE SPECIMENS RELATIVE TO PAST TUBE LOTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5409013 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CUSTOMER COMPLAINT RECEIVED STATING HIGH RATE OF POSITIVE AND GREY-ZONE RESULTS FOR RECRUIT TB SCREENING TESTS SEEN AT 2 SITES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408534 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CUSTOMER COMPLAINT RECEIVED REPORTING HIGH RATE OF POSITIVE AND GREY ZONE RESULTS FOR RECRUIT TB SCREENING AT HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408516 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CUSTOMER COMPLAINT RECEIVED STATING THAT THE RATIOS OF POSITIVE AND GRAY ZONES WERE HIGH IN THE MEDICAL CHECKUPS FOR 30 HEALTHCARE WORKERS AND 42 INPATIENTS. SIMILAR CASES WERE SEEN IN THE SAME LOT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408497 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CELLESTIS CUSTOMER COMPLAINT #(B)(4) RECEIVED INQUIRING ABOUT AN INCREASE IN POSITIVE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408494 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CELLESTIS CUSTOMER COMPLAINT #(B)(4) RECEIVED REPORTING HIGH NUMBER OF POSITIVES IN EMPLOYEE HEALTH TESTING. THE SAME PLASMA SPECIMENS WERE RE-TESTED A SECOND TIME AND THE HIGH NUMBER OF POSITIVE RESULTS WAS REPRODUCIBLE. THE CUSTOMER STATES THE TECHNICIAN RUNNING THE ELISA KIT IS EXPERIENCED, HOWEVER A NEW PHLEBOTOMIST MAY HAVE DRAWN SAMPLES IN EMPLOYEE HEALTH. THE CUSTOMER BELIEVES THAT NO TUBE MISHANDLING OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408488 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CELLESTIS CUSTOMER COMPLAINT (B)(4) RECEIVED STATING THAT A PATIENT TESTED POSITIVE AND UPON RE-TEST ONE MONTH LATER WAS NEGATIVE. THE CUSTOMER IS CONCERNED THAT THEIR GENERAL FALSE POSITIVE RATE IS AT (B)(6) IN ACCORDANCE WITH THEIR RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408486 ↗
• MalfunctionFeb 3, 2016Nonstandard Device; Incorrect, Inadequate or Imprecise Result or Readings

  CELLESTIC CUSTOMER (B)(4) RECEIVED WHERE CUSTOMER REPORTED THAT THEY DREW 5 SAMPLES ON MONDAY ((B)(6)) BEFORE TRAINING. DURING THE FIRST DAY OF TRAINING , THE SAMPLES WERE RUN AND ALL RESULTED AS POSITIVE. THEY STATED THAT THEY HAD WORKED IN MANY DIFFERENT LABS IN THE HOSPITALS AND WITH LOTS OF PATIENTS. THAT SAME DAY THE SAMPLES WERE REDRAWN PLUS AN ADDITIONAL 2 SAMPLES. THEY REPEATED AS POSITIVE ON THE SECOND DAY OF TRAINING, WITH THE ADDITIONAL 2 SAMPLES AS NEGATIVE. THE VALIDATION SAMPLES THAT WERE SUPPLIED RESULTED AS EXPECTED WITH A MIXTURE OF POSITIVES AND NEGATIVE RESULTS. THE CUSTOMER SENT THE 7 TUBES THAT WERE DRAWN FOR THE SECOND DAY OF TESTING TO THEIR LAB IN SIOUX FALLS, AND THEY CONFIRMED THE POSITIVE AND NEGATIVE RESULTS. THE CUSTOMER THEN ORDERED A NEW TUBE LOT AND REDREW THE SAME 7 SAMPLES. THEY RAN THESE SAMPLES IN THEIR LAB AND SENT THEM TO MAYO TO RUN. ALL ARE NEGATIVE. THEY ARE CONVINCED THAT IT IS THE LOT OF TUBES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408484 ↗
• MalfunctionFeb 3, 2016False Positive Result; False Positive Result

  CELLESTIS CUSTOMER COMPLAINT #(B)(4) WAS RECEIVED THAT STATES THROUGHOUT THE MONTH OF (B)(6) 2012 THE CUSTOMER WAS SEEING A DRAMATIC INCREASE IN POSITIVE RESULTS, WHERE THE PREVIOUS QFT TEST WAS NEGATIVE WITH NO RISK FACTORS. PREVIOUS MONTHS DID NOT SHOW A SIGNIFICANT INCREASE AS DID (B)(6). PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS FOUND TO BE MALFUNCTIONING AND SUBSEQUENTLY RECALLED (RECALL REFERENCE #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5408477 ↗

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 · Terminated
  QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
• Z-0888-2013 · Sep 27, 2012 · Terminated
  VACUETTE 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
• Z-0889-2013 · Sep 27, 2012 · Terminated
  Vacuette 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