ThinPrep Imaging System ThinPrep Imaging System Imaging StationRecalls & reported problems
Hologic, Inc. · A system for imaging and analyzing ThinPrep® cervical cyctology sample slides. · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045500921), received between Mar 1, 2022 and Mar 1, 2022 — classified as 1 malfunction.
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 16, 2026.
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.
MalfunctionMar 1, 2022False Negative Result; False Negative Result
HOLOGIC WAS INFORMED BY OUR DISTRIBUTOR THAT THE THIN PREP IMAGER'S ALGORITHM MISSED ABNORMAL CELLS DURING IMAGING. THE CYTOLOGIST PERFORMED A MANUAL SCAN ON THE MICROSCOPE AND FOUND ABNORMAL CELLS THAT THEY FEEL SHOULD HAVE BEEN MARKED AS OBJECTS OF INTEREST BY THE IMAGER. THE CUSTOMER STATED THAT THE ALGORITHM HAD NOT INCORPORATED CELLS THAT HAD A NUCLEUS THAT WAS LARGER THAN THE CYTOPLASM IN THE 22 FIELD OF VIEW (FOV) WHICH ARE AUTOMATICALLY SELECTED BY THE INSTRUMENT ALGORITHM. THESE CELLS WERE IDENTIFIED AS CANCEROUS. THE INCIDENT OCCURRED ONLY ONCE DURING SLIDE PROCESSING. THE PHYSICIAN CONFIRMED THAT THE CORRECT HOLOGIC STAIN WAS USED ON THE SLIDE. THE CUSTOMER WAS CONCERNED, AS THIS FALSE NEGATIVE RESULT COULD HAVE HAD ADVERSE EFFECTS TO THE PATIENT, HAD A MANUAL SCREEN NOT BEEN PERFORMED. IN THIS CASE, THERE WAS NO DELAY OF DIAGNOSIS TO THE PATIENT. A PHOTOGRAPH OF THE CELLS WAS PROVIDED, HOWEVER SEVERITY OF ABNORMALITY CANNOT BE ASCERTAINED BY THE PHOTOGRAPH ALONE AND WOULD REQUIRE CONFIRMATION OF DIAGNOSIS BY THE REPORTING LAB. LIMITED INFORMATION RELATIVE TO CYTOLOGIST UNDERSTANDING AND COMFORT USING THE IMAGING SYSTEM WAS PROVIDED. THE DISTRIBUTOR WILL SEND A CLINICAL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13638415 ↗
Other READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED devices
- BD™ FocalPoint™ Slide Profiler Refurbished 491490Becton, Dickinson And Company · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED13 reports
- BD FocalPoint 491085Becton, Dickinson And Company · Reader, Cervical Cytology Slide, Automated2 reports
- BD FocalPoint Slide Profiler 491464Becton, Dickinson And Company · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED2 reports
- BD FocalPoint 491086Becton, Dickinson And Company · Reader, Cervical Cytology Slide, Automated1 report
- BD FocalPoint™ Slide Profiler Refurbished 491090Becton, Dickinson And Company · READER, 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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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