# FDA recall Z-2351-2024

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2024-05-08.

## Product

BD Multitest 6-Color TBNK CE-IVD, REF: 644611;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166;  BD Multitest 6-Color TBNK, IVD, REF: 662967;  BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995.   BD Multitest" 6-Color TBNK reagent with optional BD Trucount" Tubes is a six-color direct immunofluorescence reagent.

## Reason for recall

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

## Distribution

US: MN, NJ, NY, MD, UT, FL, NC, MA, KY, NE, NV, CA, LA, DC, OH, MI, PA, WA, CT, AL, DE, TN, IN, OR, IL, WI, NH, TX, GA, RI, SD, ID, NM, AR.  OUS: CA, SG, NZ, AU, KR, IN, PE, GT, AR, MX, TW, CN, NI, CR, JP, BR, TH, BE, VN

## Key facts

- **Recall number:** Z-2351-2024
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-08
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2351-2024

## Citation

> AI Analytics. FDA recall Z-2351-2024. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2351-2024. Source: US FDA. Licensed CC0.

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