Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0172-2023

Z-0172-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
November 9, 2022
Initiation Date
October 3, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,709 tubes (corrected 11/04/2022)

Product Description

BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes in blood. BD Trucount Tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount Tubes can be used with the BD FACS Loader.

Reason for Recall

Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

Distribution Pattern

U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, and WI O.U.S.: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Korea, Mexico, Malaysia, New Zealand, Panama, Peru, Philippines, Paraguay, Singapore, Thailand, Taiwan, and Uruguay

Code Information

Corrected as of 11/04/2022: Catalog Number: 663028 UDI-DI Code: 00382906630285 Lot Numbers: 2031238 2063994 2095615 2145791 2221697 2237045

Other recalls by Becton, Dickinson and Company, BD Biosciences

  • Z-2351-2024 Class II — BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit wi (May 8, 2024)
  • 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-0173-2023 Class II — BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for (October 3, 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-1215-2022 Class II — BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-K (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-0072-2020 Class II — BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using (August 19, 2019)