BioFire® Joint Infection (JI) Panel RFIT-ASY-0138Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815381020192), received between Apr 1, 2026 and May 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Aug 12, 2026Open, Classified

   Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results

   Z-0150-2027 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Apr 22, 2026Class IIOpen, Classified

   Contamination to in-vitro diagnostic test may result in false positives.

   Z-2067-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026False Positive Result

  THE CUSTOMER (POLAND) REPORTED A POTENTIAL FALSE POSITIVE MRSA RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PERIPROSTHETIC TISSUE SAMPLE. NOTE, THIS SAMPLE TYPE IS CONSIDERED OFF-LABEL USE. THE CUSTOMER REPORTED THE PATIENT WAS AFFECTED DUE TO EXCESSIVE ANTIBIOTIC TREATMENT. THE CUSTOMER DID NOT CONSIDER THE TREATMENT INAPPROPRIATE BUT NOTED THAT IT WAS EXCESSIVE. THE CUSTOMER REPORTED THERE WAS NO DETERIORATION IN HEALTH DUE TO THE TREATMENT AT THIS TIME. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE CUSTOMER WAS TESTING AN OFF-LABEL SAMPLE TYPE. HOWEVER, THE CUSTOMER REPORTED THESE RESULTS FOLLOWING RECEIPT OF FIELD SAFETY CORRECTIVE ACTION, FA-TWD-000074, WHICH IDENTIFIED AN INCREASED RISK OF FALSE POSITIVE S. AUREUS ON KIT/POUCH LOT 0878825/3RXZ25.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318410 ↗
• MalfunctionMay 28, 2026False Positive Result

  THE CUSTOMER (POLAND) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PERIPROSTHETIC TISSUE SAMPLE. NOTE, THIS SAMPLE TYPE IS CONSIDERED OFF-LABEL USE. THE CUSTOMER REPORTED THE PATIENT WAS AFFECTED DUE TO EXCESSIVE ANTIBIOTIC TREATMENT. THE CUSTOMER DID NOT CONSIDER THE TREATMENT INAPPROPRIATE BUT NOTED THAT IT WAS EXCESSIVE. THE CUSTOMER REPORTED THERE WAS NO DETERIORATION IN HEALTH DUE TO THE TREATMENT AT THIS TIME. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. DURING THE INVESTIGATION IT WAS DETERMINED THAT THE CUSTOMER WAS TESTING AN OFF-LABEL SAMPLE TYPE. HOWEVER, THE CUSTOMER REPORTED THESE RESULTS FOLLOWING RECEIPT OF FIELD SAFETY CORRECTIVE ACTION, FA-TWD-000074, WHICH IDENTIFIED AN INCREASED RISK OF FALSE POSITIVE S. AUREUS ON KIT/POUCH LOT 0878825/(B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318403 ↗
• MalfunctionMay 26, 2026False Positive Result

  SUMMARY: (B)(6) HOSPITAL (B)(6) (B)(6) REPORTED A POTENTIAL FALSE POSITIVE RESULT ON THE BIOFIRE JOINT INFECTION PANEL (JI) PANEL AFTER TESTING A PATIENT'S SYNOVIAL FLUID (SF). THE CUSTOMER REPORTED THAT DUE TO THE BIOFIRE RESULT THE PATIENT WAS TREATED WITH ANTI-STAPHYLOCOCCAL ANTIBIOTICS. THE PATIENT¿S CONDITION WAS MOST LIKELY ATTRIBUTABLE TO A POSTOPERATIVE HEMATOMA. THE ANTIBIOTIC TREATMENT WAS MAINTAINED EMPIRICALLY DUE TO THE TKA-RELATED COMPLICATION. NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. BIOFIRE HAS REQUESTED FURTHER INFORMATION FROM THE CUSTOMER AND IS CURRENTLY INVESTIGATING THIS EVENT. SIMILAR EVENTS WERE RECENTLY OBSERVED IN THE FIELD, WITH JI PANEL KIT LOTS 0878825 AND 0883425 HAVING AN ELEVATED RISK FOR FALSE POSITIVE STAPHYLOCOCCUS AUREUS. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED ON (B)(6) 2026, VIA (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25279365 ↗
• MalfunctionApr 1, 2026False Positive Result

  SUMMARY: THE CUSTOMER (BARCELONA, SPAIN) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT'S SAMPLE. THE CUSTOMER INDICATED THE S. AUREUS RESULT WAS REPORTED TO THE CLINICIAN, AND THE PATIENT WAS TAKEN TO THE SURGERY ROOM WITHOUT IT BEING NECESSARY. HOWEVER, NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULTS WAS CONTAMINATION DURING MANUFACTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760910 ↗
• MalfunctionApr 1, 2026False Positive Result

  THE CUSTOMER (USA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PATIENT SAMPLE. THE CUSTOMER REPORTED THE PATIENT WAS NOT IMPACTED. NO PATIENT HARM WAS REPORTED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY THE CAUSE OF THE FALSE POSITIVE S. AUREUS RESULT WAS CONTAMINATION DURING MANUFACTURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760769 ↗
• MalfunctionApr 1, 2026False Positive Result

  SUMMARY: THE CUSTOMER (ZAMS, AUSTRIA) REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE® JOINT INFECTION (JI) PANEL AFTER TESTING A PATIENT BIOPSY SAMPLE. THE CUSTOMER REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT DUE TO THE JI PANEL RESULT, AND THE CUSTOMER STATED THE PATIENT WAS NOT HARMED. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY THE CAUSE OF THE FALSE POSITIVE S. AUREUS RESULT WAS CONTAMINATION DURING MANUFACTURING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24754527 ↗