BD FocalPoint Slide Profiler 491464Recalls & reported problems
Becton, Dickinson And Company · BD FocalPoint Slide Profiler (RoHS, Universal Voltage) · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382904914646), received between Nov 11, 2021 and Apr 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (2 reports).
1 other recall cover devices cleared under the same FDA submission (P950009); they may or may not involve this specific model.
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 Result2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2024False Negative Result; False Negative Result
IT WAS REPORTED THAT THE BD FOCALPOINT¿ SLIDE PROFILER CLASSIFIED A SLIDE AS NEGATIVE REQUIRING NO FURTHER REVIEW. THE SLIDE WAS REVIEWED BY THE LABORATORY AND DETERMINED TO BE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19163973 ↗MalfunctionNov 11, 2021False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE TESTING WITH BD INSTRUMENT FOCALPOINT CE UNIVERSAL A FALSE NEGATIVE RESULT WAS OBTAINED. PATHOLOGIST REVIEWED, AND IT TURNED OUT TO BE A NON HPV ASSOCIATED CERVICAL ADENO CARCINOMA OF THE GASTRIC TYPE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PAP SMEAR WAS CLASSIFIED BY FOCALPOINT AS NO FURTHER REVIEW. AFTER REVIEWING BY A CYTO TECH AND A PATHOLOGIST, IT TURNED OUT TO BE A NON HPV ASSOCIATED CERVICAL ADENO CARCINOMA OF THE GASTRIC TYPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12800572 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950009. One submission often covers many models, so check the product and lot details in each record.
- Z-0081-2019 · Sep 21, 2018 · TerminatedBD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to a
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 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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