Recall archive / FDA device enforcement
BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 3371... — FDA record Z-2351-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Becton, Dickinson and Company, BD Biosciences
- Quantity
- 10,027
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2351-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alabama
- Arkansas
- California
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Dakota
- Tennessee
- Texas
- Utah
- Washington
- Wisconsin
Dates in the source
- Report date
- Jul 24, 2024
- Recall initiation date
- May 8, 2024
- Center classification date
- Jul 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.