Panther Fusion® AMR KIT, PANTHER FUSION, 96T, IVDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15420045509290), received between Oct 22, 2019 and Feb 3, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Imprecise or Erratic Results” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2023Imprecise or Erratic Results; Imprecise or Erratic Results

  HOLOGIC BECAME AWARE OF A POTENTIAL FALSE POSITIVE HMPV RESULT SUBMITTED TO THE FDA (MDR REPORT KEY (B)(4). THE INCIDENT OCCURRED ON (B)(6) 2019, BUT HOLOGIC BECAME AWARE OF THE INCIDENT ON 01/05/2023. A PATIENT WAS TESTED FOR HUMAN METAPNEUMOVIRUS (HMPV) AND RHINOVIRUS (RV) USING THE PANTHER FUSION ADV/HMPV/RV ASSAY LOT: 247667. THE SAMPLE WAS RV-POSITIVE WITH A STRONG PCR SIGNAL AND HMPV-POSITIVE WITH A WEAK PCR SIGNAL. WHEN RETESTED, THE SAMPLE TEST RESULTS WERE STILL RV- AND HMPV-POSITIVE. THE FOLLOWING WEEK, TWO OTHER PATIENTS TEST POSITIVE FOR BOTH RV AND HMPV WITH THE SAME PCR SIGNAL RESULT, LEADING THE USER TO QUESTION THE INITIAL PATIENT¿S SAMPLE RESULT AS A POTENTIAL FALSE POSITIVE. THE INFORMATION REPORTED IN THE MDR IS INSUFFICIENT TO CHARACTERIZE ANY SAMPLE AS A CONFIRMED FALSE RESULT. HOLOGIC WAS NOT CONTACTED NOR MADE AWARE OF ANY RESULTS REPORTED, ANY AMENDMENTS TO RESULTS, OR ANY TREATMENT PROVIDED. USER CONTACTED THE VENDOR, WHO STATED THEY UNDERSTOOD THE CAUSE OF THIS ISSUE AND DID NOT ISSUE GUIDANCE TO CUSTOMERS. A PREVIOUS EVENT SEARCH PERFORMED ON (B)(6) 2023 FOUND NO SIMILAR COMPLAINTS ASSOCIATED WITH LN: 247667 SINCE ON (B)(6) 2019; THE ISSUE WITH ASSAY LOT:

  Patient problems: Insufficient Information

  MAUDE report 16296619 ↗
• InjuryOct 22, 2019Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  CUSTOMER REPORTED THEY HAD DUAL POSITIVE SAMPLES (UNKNOWN NUMBER OF SAMPLES) FOR RV AND HMPV WHEN RUNNING THE ADV/HMPV/RV ASSAY ON THE PANTHER-FUSION. THESE DUAL POSITIVE SAMPLES HAD EARLY RV CYCLE TIMES ASSOCIATED WITH HIGH VIRAL CONTENT AND LATE HMPV CYCLE TIMES WITH A SLOW RAMP UP TO POSITIVITY. PER THE CUSTOMER'S PROCEDURE, THEY RETESTED THE DUAL POSITIVE RESULTS USING A NEW ALIQUOT OF VIRAL MEDIUM PLACED INTO A NEW STM TUBE. ONE SAMPLE THAT WAS ORIGINALLY DUAL RV AND HMPV POSITIVE THEN HMPV RETESTED AS NEGATIVE. HOLOGIC TECHNICAL SUPPORT (TS) REVIEWED THE CUSTOMER PANTHER LOGS. HOLOGIC DETERMINED THE CUSTOMER RESULTS SHOULD NOT BE COMPARED AS THEY ARE FROM DIFFERENT ALIQUOTS. THE RESULT DISCREPANCY WAS LIKELY TO BE DUE TO A LOW TARGET. TS INFORMED CUSTOMER THAT THERE IS A RISK OF HMPV OR ADV FALSE POSITIVE RESULT FOR SAMPLES CONTAINING A HIGH RHINOVIRUS VIRAL CONTENT. A RISK ASSESSMENT WAS COMPLETED, AND THE OVERALL RISKS ASSOCIATED WITH DUAL POSITIVE RESULTS IS THAT THE PROBABILITY OF INCORRECT RESULTS IS REMOTE AND THE CONSEQUENCES ARE NEITHER SEVERE NOR LIFE-THREATENING. ALTHOUGH THE POSSIBILITY OF DUAL POSITIVE RESULTS IS PART OF HOLOGIC'S LABELING, HOLOGIC UPDATE THE LABE

  Patient problems: Respiratory Tract Infection

  MAUDE report 9221135 ↗