Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0171-2023

Z-0171-2023 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
52,570 tubes (corrected on 11/04/2022)

Product Description

BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes 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

Added/Corrected as of 11/04/2022: Catalog Number: 340334 UDI-DI Code: 00382903403349 Lot Numbers: 2031144 2034642 2035110 2035121 2060660 2073297 2073298 2095186 2101458 2108676 2112862 2152055 2152064 2152068 2152075 2152080 2203024 2208091 2215812 2235269 2223229 2236782 2236934 2236936 2236937 2236783 2237006 2237008 2237012 2237014 2237015 2237016

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