# FDA recall Z-0171-2023

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2022-10-03.

## 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.

## 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

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

## Key facts

- **Recall number:** Z-0171-2023
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-03
- **Report date:** 2022-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0171-2023

## Citation

> AI Analytics. FDA recall Z-0171-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0171-2023. Source: US FDA. Licensed CC0.

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