Z-2351-2024 Class II Ongoing
FDA device recall Z-2351-2024 was initiated by Becton, Dickinson and Company, BD Biosciences on May 8, 2024 and is designated Class II. 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 ev… The recall status is ongoing. Affected quantity: 10,027.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2024
- Initiation Date
- May 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,027
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.
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 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
Code Information
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