ThinPrep 5000 Processor TP-5000 Autoloader Accessory KitRecalls & reported problems
Hologic, Inc. · Accessory kit with components for installation of the ThinPrep® 5000 processor with autoloader. · Class 3
Data updated Oct 13, 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 15420045513952), received between Jan 12, 2026 and Jan 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
InjuryJan 12, 2026Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER REPORTED TO HOLOGIC THAT THEY EXPERIENCED A URINE STAINING PROBLEM THAT RESULTED IN INCORRECT RESULTS AND A MISDIAGNOSIS. THE CUSTOMER REPORTED RED SPOTS ON THE CELL¿S CYTOPLASM AND ALSO A ¿RED BATH¿ OBSERVED FROM THE THINPREP® 5000 AUTOLOADER INSTRUMENT. HOLOGIC HAS CONFIRMED THAT NO RED DYES OR MATERIALS ARE PRESENT IN THE THINPREP® 5000 AUTOLOADER. HOLOGIC¿S CYTOLOGY APPLICATIONS SPECIALIST (CAS) HAS CONTACTED THE CUSTOMER MULTIPLE TIMES TO OBTAIN ADDITIONAL INFORMATION REGARDING THE NATURE OF THE MISDIAGNOSIS, THE ASSOCIATED PATIENT OUTCOME, THE TYPE OF IMAGER USED, AND FURTHER DETAILS ON THE ALLEGED INSTRUMENT ISSUE; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE.
Patient problems: Insufficient Information
MAUDE report 24045343 ↗
Other Processor, cervical cytology slide, automated devices
- BD SurePath™ Collection Vial 491452Becton, Dickinson And Company · Processor, cervical cytology slide, automated82 reports
- BD Totalys SlidePrep 491346Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated53 reports
- BD PrepStain Slide Processor 490100Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated24 reports
- BD Totalys MultiProcessor 443327Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated13 reports
- BD Totalys™ MultiProcessor Consumables Kit 491453Becton, Dickinson And Company · Processor, cervical cytology slide, automated4 reports
- BD PrepStain Slide Processor 490407Becton, Dickinson And Company · Processor, Cervical Cytology Slide, Automated4 reports
- BD PrepStain Slide Processor 490410Tripath Imaging, Inc. · Processor, Cervical Cytology Slide, Automated2 reports
- BD PrepStain™ Consumables Kit 491454Becton, Dickinson And Company · Processor, cervical cytology slide, automated1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page