APTIMA MYCOPLASMA GENITALIUM ASSAY
Received Jun 5, 2026 · Event occurred May 22, 2026
Report 2024800-2026-00029 · MDR key 25411000
Device
Generic name
Nucleic Acid Detection System For Non-viral Microorganism(s)
Manufacturer
Hologic, Inc.Catalog number
ASY-09407
Lot number
920257
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
HOLOGIC REVIEWED THE PANTHER LOGS AND WORKLISTS AND NOTED THERE WERE NO INDICATIONS OF HARDWARE OR REAGENT PREPARATION ISSUES THAT AFFECTED RESULTS. CUSTOMER NOTED THAT THERE WAS A POSSIBILITY THE SAMPLES WERE SWAPPED. HOLOGIC HAS NOT LEARNED OF ANY PATIENT TREATMENT OR ADVERSE PATIENT OUTCOMES DUE TO THIS EVENT.
Description of Event or Problem
ON (B)(6) 2026, CUSTOMER REPORTED RECEIVING DISCREPANT RESULTS WHILE USING THE APTIMA MYCOPLASMA GENITALIUM ASSAY (ML 920257) ON A PATIENT SAMPLE THAT WAS PART OF THEIR BI-ANNUAL INSTRUMENT COMPARISON STUDY. ON (B)(6) 2026, CUSTOMER TESTED SAMPLES ON THE PANTHER INSTRUMENT SN (B)(6) WITH WORKLIST (WL) ID (B)(4) AND RECEIVED A NEGATIVE RESULT FOR SAMPLE ID (B)(6). ON (B)(6) 2026, CUSTOMER TESTED SAMPLES ON THE PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)() AND RECEIVED A POSITIVE RESULT FOR SAMPLE ID (B)(6). ON (B)(6) 2026 CUSTOMER RETESTED SAMPLES ID (B)(6) ON A DIFFERENT PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)(4). A POSITIVE RESULT WAS RECEIVED FOR SAMPLE ID (B)(6) AND A NEGATIVE RESULT WAS RECEIVED FOR SAMPLE ID (B)(6). ON (B)(6) 2026, CUSTOMER RETESTED BOTH SAMPLES ONE MORE TIME ON THE PANTHER INSTRUMENT SN (B)(6) WITH WL ID (B)(4) AND RECEIVED THE SAME RESULTS, POSITIVE FOR SAMPLE ID (B)(6) AND NEGATIVE FOR SAMPLE ID (B)(6).CUSTOMER NOTED THAT THERE WAS A POSSIBILITY THAT THE SAMPLE IDS WERE SWAPPED DURING THE SECOND AND THIRD RETESTS. CUSTOMER DID NOT PROVIDE ANY INFORMATION ON THE PATIENT OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.