# FDA recall Z-0009-2025

> **Becton, Dickinson and Company, BD Bio Sciences** · Class II · device recall initiated 2024-08-12.

## Product

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1.    Intended use: to prepare human specimens to be analyzed.

## Reason for recall

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

## Distribution

US: NJ, UT, WI, TX, ID, AK, MN, MA, MD, TN, MI, CA, VA  OUS: Ireland, Austria, Italy, Germany, Belgium, Finland, Canada, France, Spain, New Zealand, United Kingdom, Japan, Australia, Norway, Singapore, Sweden, Turkey, Brazil, Colombia, Netherlands, United Arab Emirates, Saudi Arabia, Mexico, Switzerland, Costa Rica, China, Azerbaijan, Algeria, Jordan, India

## Key facts

- **Recall number:** Z-0009-2025
- **Recalling firm:** Becton, Dickinson and Company, BD Bio Sciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-12
- **Report date:** 2024-10-09

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0009-2025

## Citation

> AI Analytics. FDA recall Z-0009-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0009-2025. Source: US FDA. Licensed CC0.

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