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N/A 662961Recalls & reported problems

Becton, Dickinson And Company · Kit FC Beads 7 Color US IVD · Class 2

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 00382906629616), received between Feb 15, 2023 and Feb 15, 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. How this data works · Data updated Oct 13, 2026.

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.

  • MalfunctionFeb 15, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT WHILE USING THE BD® FC BEADS 7-COLOR KIT THAT THERE WAS INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I AM PERFORMING REFERENCE SETTING UPDATES AND NOTED THE FOLLOWING WITH THIS LOT#2339327 OF 7 COLOUR FC BEADS WHEN I USED THE BARCODE STICKER TO ADD THE NEW FC BEAD LOT INFORMATION THE TUBE LOT#' S IN THE BOX DID NOT MATCH THE LOT NUMBERS FROM THE SCANNED BARCODE. WHEN I WENT AND DOWNLOADED THE BEAD-LOT FILE FROM ONLINE, IT WAS CORRECT. JUST WANTED TO GIVE YOU A HEADS UP.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16381065 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.