FDA Device recall Z-0009-2025
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339 by Becton Dickinson And Bd Bio Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0009-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-12 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Bio Sciences |
| Distribution | AK, CA, ID, MA, MD, MI, MN, NJ, TN, TX, UT, VA, WI |
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.
Identifiers
| code_info | REF/UDI-DI/Serial Numbers: 666340/382906663405/9230010101, 9230010102, 9230010103, 9230010104, 9230010105, 9230010107,…REF/UDI-DI/Serial Numbers: 666340/382906663405/9230010101, 9230010102, 9230010103, 9230010104, 9230010105, 9230010107, 9230010108, 9230010109, 9230010112, 9230010113, 9230010114, 9230010115, 9230010116, 9230010118, 9230010119, 9230010120. 666339/9230000102, 9230000103, 9230000104, 9230000105, 9230000106, 9230000112, 9230000113, 9230000114, 9230000118, 9230000120, 9230000121, 9230000123, 9230000124, 9230000126, 9230000128, 9230000130, 9230000132, 9230000134, 9230000135, 9230000138, 9230000144, 9230000145, 9230000131, 9230000152, 9230000149, 9230000030, 9230000101, 9230000108, 9230000109, 9230000110, 9230000111, 9230000115, 9230000116, 9230000117, 9230000119, 9230000122, 9230000125, 9230000127, 9230000129, 9230000136, 9230000139, 9230000141, 9230000142, 9230000143. 663128/382906631282/9220030004, 9220030005, 9220030008, 9220030016, 9220030017, 9220030027, 9220030029, 9220030031, 9220030043, 9220030053, 9220030057. 662588/9220010119, 9220010179, 9220010182, 9220010232, 9220010236, 922 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0009-2025%22
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