BD FocalPoint 491085Recalls & reported problems
Becton, Dickinson And Company · BD FocalPoint™ Slide Profiler is an automated cytology screening device that classifies slides using a high speed video microscope, digital camera, and image interpretation software. Slide results data are presented through reports from the BD FocalPoint Workstation Computer. BD FocalPoint instrument with digital imaging system. · Class 3
Data updated Oct 16, 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 00382904910853), received between May 7, 2022 and Jan 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
- False Negative Result1
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.
MalfunctionJan 23, 2026Contamination
IT WAS REPORTED AFTER USING BD FOCALPOINT, CONTAMINATION FROM THE HUMAN GENOME WAS PRESENT ON THE INSTRUMENT, WHICH CAUSED AN ILLUMINATION ERROR. OTHER SPECIFIC CONTAMINATION INFORMATION WAS NOT REPORTED FROM THE CUSTOMER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24160902 ↗MalfunctionMay 7, 2022False Negative Result; False Negative Result
IT WAS REPORTED THAT WHILE USING BD FOCALPOINT¿ SLIDE PROFILER THE CUSTOMER RECEIVED FALSE NEGATIVE RESULTS. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS AN HSIL (SEVERE DYSPLASIA) SAMPLE AT RANK 4, AND FOV (FIELD OF VIEW) DEVIATION WAS OBSERVED IN THE SITE NAVIGATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14323546 ↗
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 Slide Profiler 491464Becton, Dickinson And Company · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED2 reports
- 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
- 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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