ALINITY M STI AMP KIT

Additional Manufacturer Narrative

AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED INTERNATIONALLY USING THE ALINITY M STI ASSAY, LIST NUMBER 09N17-091, WHICH IS THE SAME/ SIMILAR TO THE ALINITY M STI ASSAY, LIST NUMBER 09N17-095, WHICH RECEIVED FDA APPROVAL.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE CHLAMYDIA TRACHOMATIS (CT) RESULT WHEN RUNNING THE ALINITY M STI ASSAY. SAMPLE ID (B)(6) TESTED ON (B)(6) 2026 HAD AN AMPLIFICATION CURVE FOR CT, BUT THE ASSAY REPORTED THE RESULT AS "NOT DETECTED". THE CUSTOMER DID NOT BELIEVE THE RESULT, SO THE SAMPLE WAS TESTED WITH AN ALTERNATIVE METHOD, AND RESULT WAS POSITIVE. THE ASSAY PERFORMANCE MET ALL SYSTEM ACCEPTANCE CRITERIA. THE RESULT FOR THE SAMPLE HAD VALID INTERNAL CONTROL (IC) AT CYCLE THRESHOLD 29.85, VALID CELLULAR CONTROL (CC) AT CYCLE THRESHOLD 25.22, AND AMPLIFICATION FOR CT, WHICH DID NOT REACH THE MINIMUM MAX RATIO (MR) VALUE. THE MINIMUM EXPECTED IS 0.075 AS PER SPECIFICATIONS, BUT THE CURVE HAS A VALUE OF 0.064. THEREFORE, THE RESULT FOR CT WAS GIVEN AS "NOT DETECTED", WITH A CYCLE NUMBER (CN) VALUE ASSIGNED OF -1.0 CN. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.