Reported Jul 24, 2024 · Ongoing

BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF:…

Becton, Dickinson and Company, BD Biosciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812

Is this the product you have?

4 products · 12 lot codes

  1. 644611BD Multitest 6-Color TBNK CE-IVD

    UDI-DI
    382906446114

    3 recalled lot codes

    • 20010-31-Aug-24
    • 49510-30-Sep-24
    • 32674-30-Sep-24
  2. 337166BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD

    UDI-DI
    382903371662

    3 recalled lot codes

    • 17569-31-Jul-24
    • 22709-31-Aug-24
    • 49517-30-Sep-24
  3. 662967BD Multitest 6-Color TBNK, IVD

    UDI-DI
    382906629678

    5 recalled lot codes

    • 17572-31-Jul-24
    • 17582-31-Jul-24
    • 26797-31-Aug-24
    • 69761-30-Sep-24
    • 49506-30-Sep-24
  4. 662995.BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.

    UDI-DI
    382906629951

    1 recalled lot code

    • 49508-30-Sep-24
Amount recalled
10,027

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.