ACCUPROBE® KIT,ACCUPROBE,M. TUBERCULOSISRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045506169), received between Sep 14, 2017 and Sep 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “False Negative Result” (1 report).

1 other recall cover devices cleared under the same FDA submission (K896493); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2017False Negative Result

  THE CUSTOMER, (B)(6) AT (B)(6), OBTAINED A PATIENT ISOLATE AT THE END OF JULY. THE PATIENT SAMPLE WAS GROWN ON A MYCOBACTERIA GROWTH INDICATOR TUBE (MGIT) AND THE SMEAR WAS ACID-FAST BACILLI (AFB) POSITIVE AND EXHIBITED "DRAGON" CORDING, CONSISTENT WITH MYCOBACTERIUM TUBERCULOSIS COMPLEX (MTBC) MORPHOLOGY. THE CUSTOMER TESTED THE PATIENT SAMPLE USING HOLOGIC'S ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX CULTURE IDENTIFICATION TEST AND TWICE OBTAINED A (B)(6) RESULT. CUSTOMER STATED THEY ARE CONFIDENT THIS PATIENT HAS (B)(6). THE RUN RESULTS WERE REVIEWED BY HOLOGIC, WHICH DEMONSTRATED THAT THE CONTROL VALUES WERE STRONG AND THAT THERE WERE OTHER POSITIVE SAMPLES IN THE RUN OBTAINED BY THE CUSTOMER. THE CUSTOMER RETESTED THE ORIGINAL SPECIMEN USING THE CEPHEID GENEXPERT MTB/RIF ASSAY AND FOUND THE SPECIMEN TO BE MTBC-POSITIVE. THE GENEXPERT MTB/RIF ASSAY IS A NEWER GENERATION SYSTEM THAT USES REAL-TIME POLYMERASE CHAIN REACTION (PCR) TO AMPLIFY THE TARGET DNA STRANDS FOR DETECTION, WHILE THE ACCUPROBE SYSTEM IS A NON-AMPLIFIED DETECTION SYSTEM. COMBINED, THESE DATA SUGGESTS THAT THE ACCUPROBE MTBC TEST POTENTIALLY GAVE A FALSE NEGATIVE RESULT. ADDITIONAL SAMPLES TAKEN FROM THE SAME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6867429 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K896493. One submission often covers many models, so check the product and lot details in each record.

• Z-1438-2011 · Dec 30, 2008 · Terminated
  Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.