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BD Multitest™ 340503Recalls & reported problems

Becton, Dickinson And Company · BD Multitest™ IMK Kit · 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 00382903405039), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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

  • Incorrect, Inadequate or Imprecise Result or Readings1

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.

  • MalfunctionNov 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT BD MULTITEST IMK KIT RESULTED IN ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE % OF CD19 IN THE ANALYZED SAMPLES ARE LOWER THAN EXPECTED. HOWEVER, IN THE MULTICHECK CONTROL THE PERCENTAGES ARE CORRECT. THE SAMPLES WERE PATIENT SAMPLES BUT THERE WAS NO IMPACT AND NO HARM ON THE PATIENTS, SINCE THE ERRONEOUS RESULTS HAVE NOT BEEN USED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12824132 ↗

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