ALINITY M STI AMP KIT

Additional Manufacturer Narrative

UPDATED H11. NO LONGER TIED TO 3005248192-2026-00026. INVESTIGATION IS PENDING.

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. ADDITIONAL MDR SUBMITTED: 3005248192-2026-00026.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT FOR THE CHLAMYDIA TRACHOMATIS (CT) TARGET ON THE ALINITY M STI AMP KIT. THE CUSTOMER REPORTED THAT DESPITE A NORMAL-LOOKING AMPLIFICATION CURVE, THE INSTRUMENT HAD A RESULT OF "CT NEGATIVE" AND NO CYCLE NUMBER. THEY RAN THE SAMPLE TWICE (SAMPLE IDS ASSOCIATED ARE (B)(6). BOTH TIMES THEY GOT THE SAME NEGATIVE RESULT. RUN DATE SAMPLE ID RESULT (B)(6) 2026 (B)(6) CT NEGATIVE (B))(6) 2026 (B)(6) CT NEGATIVE RESULTS WERE GIVEN AS "CT NEGATIVE" DUE TO MR VALUE NOT REACHING THRESHOLD (0.075). THE CUSTOMER CONSIDERED THE NEGATIVE RESULT INCORRECT. THE CUSTOMER TESTED ANOTHER METHOD (SEEGENE) AND RECEIVED A POSITIVE RESULT. A NEW SAMPLE COLLECTION IS NOT PLANNED. THE CUSTOMER HAS UPDATED THE REPORTED RESULT TO THE PHYSICIAN. THE CUSTOMER REPORTED THAT THE PATIENT'S START OF TREATMENT OCCURRED LATER DUE TO THE CORRECTION OF THE POSITIVE RESULT BEING COMMUNICATED ONLY TWO DAYS LATER. THE SAMPLE WAS TESTED FROM THE PRIMARY TUBE ON (B)(6), AND THE SEEGENE TEST WAS ALSO PERFORMED ON MARCH 2 FROM THE SAME PRIMARY TUBE. DUE TO THE DISCREPANCY IN RESULTS, WE RETESTED THE PRIMARY TUBE ON THE ALINITY ON (B)(6), AND THE RESULT WAS STILL NEGATIVE.