BD FACSDuet Premium Sample Preparation System — Class II medical device recall Z-0009-2025
Ongoing recall by Becton, Dickinson and Company, BD Bio Sciences, reported 2024-10-09, distributed in AK, CA, ID, MA, MD, MI, MN, NJ…. Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specime
| Recall number | Z-0009-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA, United States |
| Recall initiated | 2024-08-12 |
| Classified | 2024-10-03 |
| Reported by FDA | 2024-10-09 |
| Distributed | AK, CA, ID, MA, MD, MI, MN, NJ, TN, TX, UT, VA, WI |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, CO, CR, DE, DZ, ES, FI, FR, GB, IE, IN, IT, JO, JP, MX, NL, NO, NZ, SA, SE, SG, TR |
| Quantity | 130 |
| Reason classes | potency, software |
| UPC / GTIN / UDI-DI | 00382906631282, 00382906663405 |
| Serial numbers | 662588/9220010119, 663128/382906631282/9220030004, 666339/9230000102, 666340/382906663405/9230010101, 9220010112, 9220010120, 9220010125, 9220010127, 9220010128, 9220010130, 9220010133, 9220010138, 9220010154, 9220010161, 9220010179, 9220010182, 9220010183, 9220010188, 9220010197, 9220010215, 9220010225, 9220010231, 9220010232, 9220010236, 9220010238 and 105 more |
| Model numbers | 662588, 663128, 666339, 666340 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0009-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.