Becton, Dickinson and Company, BD Biosciences: Device Recall
Recall #Z-2351-2024 · 05/08/2024
Recall Details
- Recall Number
- Z-2351-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Becton, Dickinson and Company, BD Biosciences
- Status
- Ongoing
- Date Initiated
- 05/08/2024
- Location
- San Jose, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,027
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
Product Description
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.
Distribution Pattern
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