APTIMA PANTHER,TRICH REFRIG,V2,250T,READY MADERecalls & reported problems
Hologic, Inc. · 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 15420045515017), received between Nov 6, 2024 and Nov 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Open or Close” (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
- Difficult to Open or Close1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 6, 2024Difficult to Open or Close; Difficult to Open or Close
ON (B)(6) 2024, CUSTOMER RELAYED TO HOLOGIC THAT TECHNICIANS HAD HURT THEIR HANDS, ALLEGEDLY BY UNCAPPING OF HOLOGIC APTIMA TRICHOMONAS VAGINALIS READY-MADE-REAGENT (RMR) BOTTLES. UPON FURTHER INQUIRY, HOLOGIC BECAME AWARE THAT A TECHNICIAN HAD REPORTED WRIST STRAIN ON (B)(6) 2024 AND WAS NOT ABLE TO RETURN TO FULL WORK ACTIVITY UNTIL (B)(6). AS OF (B)(6) 2024, THE TECHNICIAN WAS STILL GOING THROUGH MEDICAL CHECKS EVERY TWO WEEKS.
Patient problems: Insufficient Information
MAUDE report 20622569 ↗
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® KIT, ATV-V2, REFRIGERATED, 100THologic, 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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