BD Cytology Stain Kit 491458Recalls & reported problems
Becton, Dickinson And Company · Kit Cytology Stain M · Class 1
Data updated Oct 18, 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 00382904914585), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
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.
MalfunctionOct 12, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem
EIT WAS REPORTED THAT WHILE USING BD CYTOLOGY STAIN KIT, THERE IS MISSING LABEL INFORMATION ON ONE PACK. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "XPIRY NO MENTIONED ON THE PACK OF CYTOLOGY STAIN KIT, CAT# (B)(4) IS 31-08-2023. WHEREAS THE EXPIRY DATE MENTIONED ON THE HEMATOXYLIN STAIN 0.75: WITH LOT# 3038847 AND EA/OG COMBO STAIN: WITH LOT# 3038858 IS 31-01-2024."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17928076 ↗
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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