BD Multitest 6-Color TBNK CE-IVD — Class II medical device recall Z-2351-2024
Ongoing recall by Becton, Dickinson and Company, BD Biosciences, reported 2024-07-24, distributed in AL, AR, CA, CT, DC, DE, FL, GA…. Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot
| Recall number | Z-2351-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2024-05-08 |
| Classified | 2024-07-12 |
| Reported by FDA | 2024-07-24 |
| Distributed | AL, AR, CA, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SD, TN, TX, UT, WA, WI |
| Quantity | 10,027 |
| UPC / GTIN / UDI-DI | 00382903371662, 00382906446114, 00382906629678, 00382906629951 |
| Lot numbers | 17582, 22709, 26797, 32674, 337166/382903371662/17569, 49506, 49510, 49517, 644611/382906446114/20010, 662967/382906629678/17572, 662995/382906629951/49508, 69761 |
| Model numbers | 337166, 6-COLOR, 644611, 662967, 662995 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2351-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.