FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Bio Sciences: 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.
- Recall number
- Z-0009-2025
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- 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.
- Status
- Open, Classified
- Initiated
- 2024-08-12
- Posted
- 2024-10-03
- Terminated
- not on file
- 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.
- Root cause
- Software change control
- Action
- On 8/12/2024, correction notices were sent to customers who were informed of the following; 1) Cease use of the sample preparation system with software version 1.4.1. until the Multidispense feature has been disabled. Patient samples can be prepared using single dispense on the sample preparation system or manually. 2) It is recommended that laboratories upgrade affected sample preparation systems to version 1.4.2 to correct the issue as soon as it is available. 3) Ensure the contents of this notification are read and understood by those within your organization. 4) Complete and return the response form via email to BDRC38@bd.com If you require further assistance, contact: 1-844-823-5433, Mon-Fri 8:00am and 5:00pm CT or email productcomplaints@bd.com. Recall related questions can be emailed to BDRC38@bd.com
- Quantity
- 130
- 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
- Lot, serial or model codes
- 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, 9220010250, 9220010265, 9220010275, 9220010293, 9220010311, 9220010313, 9220010316, 9220010324, 9220010327, 9220010335, 9220010338, 9220010341, 9220010344, 9220010348, 9220010349, 9220010292, 9220010112, 9220010120, 9220010125, 9220010127, 9220010128, 9220010130, 9220010133, 9220010138, 9220010154, 9220010161, 9220010183, 9220010188, 9220010197, 9220010215, 9220010225, 9220010231, 9220010238, 9220010240, 9220010242, 9220010244, 9220010256, 9220010257, 9220010260, 9220010263, 9220010268, 9220010269, 9220010279, 9220010280, 9220010289, 9220010290, 9220010294, 9220010296, 9220010329, 9220010332, 9220010345, 9220010354, 9230000031, 99220010292.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PER
- Firm FEI
- 3027394506
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28