APTIMA CV/TV ASSAY
Received Mar 12, 2026 · Event occurred Feb 13, 2026
Report 2024800-2026-00010 · MDR key 24581186
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Hologic, Inc.Catalog number
ASY-11569
Lot number
N/A
Product problems
- Imprecise or Erratic Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2026, CUSTOMER REPORTED RUNNING PREVIOUSLY TESTED NEGATIVE SAMPLES WITH THE APTIMA CV/TV ASSAY ON THEIR PANTHER INSTRUMENT (SN (B)(6)) AND RECEIVING POSITIVE RESULTS FROM THE SAME SAMPLE TUBES. CUSTOMER DID NOT PROVIDE FURTHER INFORMATION ON THE NATURE OF THE SAMPLES, WORKLISTS, OR THE INITIAL OR RETEST RESULTS. LIKEWISE, CUSTOMER DID NOT PROVIDE INFORMATION ON RESULT REPORTING OR PATIENT TREATMENT. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.
Additional Manufacturer Narrative
CUSTOMER ORIGINALLY CONTACTED HOLOGIC TO REPORT A HIGH TRICHOMONAS POSITIVITY RATE WHEN USING APTIMA CV/TV ASSAY LOT 910984 ON WORKLIST (B)(4). HOLOGIC REVIEWED CUSTOMER LOGS AND RECOMMENDED THE CUSTOMER TO PERFORM CLEANING AND PANEL RUNS FOR CONTAMINATION VERIFICATION. AFTER RESOLUTION OF THE OBSERVED HIGH POSITIVITY RATE, THE CUSTOMER REPORTED THAT THEY RAN THESE PREVIOUSLY TESTED NEGATIVE SAMPLES AND RECEIVED POSITIVE RESULTS. CUSTOMER DID NOT PROVIDE LOG FILES FOR THE DISCREPANT SAMPLES AND DID NOT STATE FOR WHICH ANALYTE THE INITIAL NEGATIVE AND RETEST POSITIVE RESULTS WERE. CONSIDERING THE CUSTOMER ORIGINALLY EXPRESSED CONCERN ABOUT THEIR TRICHOMONAS RESULTS, HOLOGIC ASSUMES THE DISCREPANT RESULTS WERE FOR THE TRICHOMONAS ANALYTE. HOLOGIC ATTEMPTED TO CONTACT CUSTOMER ON MULTIPLE OCCASIONS TO GATHER FURTHER INFORMATION ON THESE SAMPLES AND RESULTS WITH NO RESPONSE FROM THE CUSTOMER. HOLOGIC HAS NOT BEEN INFORMED OF ANY ADVERSE PATIENT OUTCOMES RELATED TO THIS ISSUE.