Becton, Dickinson and Company, BD Biosciences: 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.

Recall number

Z-0171-2023

Recalling firm

Becton, Dickinson and Company, BD Biosciences

Product

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.

Status

Open, Classified

Initiated

2022-10-03

Posted

2022-11-03

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

On 10/03/2022, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via FedEx tracked letters and emails informing customers, through internal investigations, the labels applied to the BD Trucount tubes are becoming detached due to an adhesive change made at a supplier. Customers are instructed to: 1. Immediately review their inventory for the specific catalog and lot numbers. 2. For any tubes where label detachment is observed, BD recommends that the clinician remove the label from the tube and, using a permanent marker, record the tube lot number as well as any other relevant information directly on the tube. Removal of the label prevents it from interfering with any auto-loading sample preparation and analysis systems, as well as from sticking to other tubes. For questions, contact North American Regional Complaint Center at: Phone: 1-844-8BD-LIFE (1-844-823-5433), Say "Recall" when prompted Mon-Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Quantity

52,570 tubes (corrected on 11/04/2022)

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K090967"]

PMA numbers

not on file

Product code

GKZ

Firm FEI

2916837

Firm city

San Jose

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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