BD™ FocalPoint™ Slide Profiler Refurbished 491490Recalls & reported problems
Becton, Dickinson And Company · Focal Point Digital Refurb 2 · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382904914905), received between Apr 9, 2026 and Apr 9, 2026 — classified as 13 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (13 reports).
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
- False Negative Result13
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 8 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832456 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 9 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832450 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 5 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832449 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 13 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832448 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 6 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832446 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 2 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832445 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 7 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832443 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 4 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832441 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 3 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832439 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 11 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832252 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 10 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832247 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER. THIS IS REPORT 12 OF 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832246 ↗MalfunctionApr 9, 2026False Negative Result
IT WAS REPORTED WHILE USING BD¿ FOCALPOINT¿ SLIDE PROFILER REFURBISHED, THERE WAS 1 FALSE NEGATIVE RESULT. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830212 ↗
Other READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED devices
- 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™ Slide Profiler Refurbished 491090Becton, Dickinson And Company · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED1 report
- ThinPrep Imaging System ThinPrep Imaging System Imaging StationHologic, Inc. · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED1 report
- BD FocalPoint 491086Becton, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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