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
644611BD Multitest 6-Color TBNK CE-IVD
- UDI-DI
382906446114
3 recalled lot codes
20010-31-Aug-2449510-30-Sep-2432674-30-Sep-24
337166BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD
- UDI-DI
382903371662
3 recalled lot codes
17569-31-Jul-2422709-31-Aug-2449517-30-Sep-24
662967BD Multitest 6-Color TBNK, IVD
- UDI-DI
382906629678
5 recalled lot codes
17572-31-Jul-2417582-31-Jul-2426797-31-Aug-2469761-30-Sep-2449506-30-Sep-24
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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