Aptima® KIT, ATV-V2, REFRIGERATED, 100TRecalls & reported problems
Hologic, Inc. · Aptima® Trichomonas vaginalis Assay, 100 test, box 1 of 2 (2°C to 8°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Panther® System. · Class 2
All models of Aptima (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045505537), received between Mar 13, 2026 and Mar 13, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “False Negative Result” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- False Negative Result1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 13, 2026False Negative Result
ON (B)(6) 2026, CUSTOMER REPORTED TO HOLOGIC USING IMPROPERLY RECONSTITUTED APTIMA TRICHOMONAS VAGINALIS (ATV) ASSAY REAGENTS. THE ATV KIT WAS RECONSTITUTED ON FEBRUARY 13, 2026, WITH THE REFRIGERATED COMPONENTS FROM MASTER LOT: 919757 AND THE ROOM TEMPERATURE COMPONENTS FROM ML 925885. THIS ATV KIT WAS THEN USED FOR TESTING OF PATIENT SAMPLES ON WL (B)(4) ON PANTHER SN#: (B)(6). THIS IS CONSIDERED OFF-LABEL USE OF THE ATV ASSAY. IT IS NOT KNOWN WHETHER THE RESULTS HAVE BEEN REPORTED OR IF THE SAMPLES WILL BE RETESTED OR RECOLLECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592006 ↗
Other Trichomonas vaginalis nucleic acid amplification test system devices
- BD MAX™ UVE Specimen Collection Kit 443376Becton, Dickinson And Company · Trichomonas vaginalis nucleic acid amplification test system3 recalls1 report
- BD MAX™ CT/GC/TV 442970Becton, Dickinson And Company · Trichomonas vaginalis nucleic acid amplification test system1 recall20 reports
- APTIMA PANTHER,TRICH REFRIG,V2,250T,READY MADEHologic, Inc. · Trichomonas vaginalis nucleic acid amplification test system1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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