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BD Multitest 662995Recalls & reported problems

Becton, Dickinson And Company · BD Multitest™ 6-Color TBNK with BD Trucount™ Tubes · Class 2

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00382906629951), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

  1. May 8, 2024Open, Classified

    Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

    Z-2351-2024 · Root cause: Material/Component Contamination · FDA record ↗

  2. Oct 3, 2022Open, Classified

    Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

    Z-0173-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

  • MalfunctionDec 13, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

    IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLE WITH 2 KITS OF BD MULTITEST¿ TBNK W/TRUCOUNT SIGNIFICANT DEBRIS WERE SEEN ON CD45 VS SSC AND CD19 VS SSC COMPARING WITH THE OTHER FROM THE SAME LOT. BOTH WERE ON THE SAME PATIENT, THERE WAS NO REPORT OF IMPACT TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 KITS FROM LOT #30568 HAVE BE FOUND QUESTIONABLE DOT PLOTS, A SIGNIFICANT DEBRIS WERE SEEN ON CD45 VS SSC AND CD19 VS SSC COMPARING WITH THE OTHER FROM THE SAME LOT. BOTH OF THEM ARE USED THE SAME PATIENT EDTA BLOOD FOR STAINING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12984329 ↗

Other Counter, differential cell devices

All Counter, differential cell devices →

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