FDA Device recall Z-2351-2024
BD Multitest 6-Color TBNK CE-IVD, REF: 644611
- FDA Device
- Class II
- ongoing
- Published 2024-07-24
On 2024-07-24 the FDA classified a Class II recall of BD Multitest 6-Color TBNK CE-IVD, REF: 644611 by Becton Dickinson And Bd Biosciences, citing multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high backgroun….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2351-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-08 |
| Published | 2024-07-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Biosciences |
| Distribution | 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 |
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
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
Identifiers
| code_info | REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24; 337166/382903371662/1…REF/UDI-DI/Lot-Expiration: 644611/382906446114/20010-31-Aug-24, 49510-30-Sep-24, 32674-30-Sep-24; 337166/382903371662/17569-31-Jul-24, 22709-31-Aug-24, 49517-30-Sep-24; 662967/382906629678/17572-31-Jul-24, 17582-31-Jul-24, 26797-31-Aug-24, 69761-30-Sep-24, 49506-30-Sep-24; 662995/382906629951/49508-30-Sep-24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2351-2024%22
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