Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2022 - (Recall #: Z-0172-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 3, 2022

Date Posted: November 9, 2022

Recall Number: Z-0172-2023

Event ID: 90866

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.

Status: Ongoing

Product Quantity: 11,709 tubes (corrected 11/04/2022)

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated