APTIMA AC2, REFRIG, 250T, READY MADERecalls & reported problems
Hologic, Inc. · Class 2
- 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 15420045514973), received between Sep 5, 2026 and Sep 5, 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. How this data works · Data updated Oct 13, 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.
InjurySep 5, 2026False Negative Result
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50625130 ↗
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- Aptima Combo 2® KIT,APTIMACOMBO2,100T,REF,CEIVD-UPDATEDHologic, Inc. · DNA-REAGENTS, NEISSERIA3 reports
- BD Viper™ System Remanufactured 442843Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA2 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.