Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-2351-2024

Z-2351-2024 Class II Ongoing

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

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

Other recalls by Becton, Dickinson and Company, BD Biosciences

  • Z-0641-2024 Class II — CD11b APC: ASR, REF: 340936, and CE, REF: 333143 (October 25, 2023)
  • Z-0171-2023 Class II — BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leu (October 3, 2022)
  • Z-0172-2023 Class II — BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leu (October 3, 2022)
  • Z-0173-2023 Class II — BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for (October 3, 2022)
  • Z-1215-2022 Class II — BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-K (March 25, 2022)
  • Z-1214-2022 Class II — BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti- (March 25, 2022)
  • Z-2333-2021 Class II — BD" Mouse IgG2a Isotype Control APC X39 ASR (July 22, 2021)
  • Z-0562-2021 Class II — BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a comple (October 5, 2020)
  • Z-1971-2020 Class II — Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-11 (March 31, 2020)
  • Z-0068-2020 Class II — BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using (August 19, 2019)