BioFire Joint Infection Panel

Additional Manufacturer Narrative

INVESTIGATION: (B)(6) \[(B)(6), GERMANY]" REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PATIENT SAMPLE. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. INVESTIGATION INTO THIS EVENT IS ONGOING AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE FULL INVESTIGATION AND ASSOCIATED CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED ON (B)(6) 2026 VIA FSCA FA-TWD-000074. CONCLUSION: N/A FOR INITIAL REPORT.

Description of Event or Problem

SUMMARY: THE CUSTOMER \[(B)(6), GERMANY]" REPORTED A POTENTIAL FALSE POSITIVE STAPHYLOCOCCUS AUREUS RESULT ON THE BIOFIRE JOINT INFECTION PANEL AFTER TESTING A PATIENT SAMPLE. IT IS UNKNOWN IF THE PATIENT WAS AFFECTED DUE TO THE JI PANEL RESULT. INFORMATION REGARDING WHETHER PATIENT CARE WAS AFFECTED HAS BEEN REQUESTED. 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 FALSE POSITIVE S. AUREUS RESULTS ON JI PANEL LOTS 0878825 AND 0883425. A FIELD SAFETY CORRECTIVE ACTION (FSCA) WAS ISSUED ON (B)(6) 2026 VIA FSCA FA-TWD-000074.