ThinPrep 5000 ProcessorRecalls & reported problems
Hologic, Inc. · Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. · 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 15420045504158), received between Feb 23, 2018 and Feb 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Facilities Issue” (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.
Most reported problems
Device problems
- Facilities Issue1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2018Facilities Issue; Facilities Issue
A CUSTOMER IN SPAIN REPORTED 5010 ERRORS INSUFFICIENT LIQUID IN VIAL ON THEIR THINPREP 5000 PROCESSOR AND TWO SAMPLES WERE LOST. PATIENT RECALL WAS NEEDED. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE CONFIRMED, BUT WAS UNABLE TO REPRODUCE ERROR. THE FSE FOUND THE FOLLOWING TO BE THE MOST LIKELY CAUSE OF THE ERROR: NEED TO PERFORM TB-01234. ALL TESTS REQUIRED IN TB-01234: PERFORMED INSPECTION PER TECHNICAL DOCUMENTATION. THE FSE RAN SAMPLE PROCESSING TESTS TO VERIFY INSTRUMENT OPERATION. PROCESSED SAMPLES TO CONFIRM OPERATION, SYSTEM OPERATIONAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7293549 ↗
Other Processor, cervical cytology slide, automated devices
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- 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.
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