Recall Z-0009-2025— Becton, Dickinson and Company, BD Bio Sciences
Class II · Ongoing
Class II FDA medical device recall by Becton, Dickinson and Company, BD Bio Sciences, initiated 2024-08-12. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-12
- Firm location
- Milpitas, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.