Z-0009-2025Class II

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System...

Name: Z-0009-2025 BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System...
Creator: Becton, Dickinson and Company, BD Bio Sciences
Published: 2024-08-12
License: https://open.fda.gov/license/

Becton, Dickinson and Company, BD Biosciences / initiated 2024-08-12 / Open, Classified / root cause: software

FDA source

Becton, Dickinson and Company, BD Bio Sciences began a recall of BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V... on 2024-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0009-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-12
Posted: 2024-10-03
Recalling firm: Becton, Dickinson and Company, BD Biosciences
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.
Product code: PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
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.
Root cause tag: software
FDA 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 [email protected] If you require further assistance, contact: 1-844-823-5433, Mon-Fri 8:00am and 5:00pm CT or email [email protected]. Recall related questions can be emailed to [email protected]
Quantity in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-10-03

Product code PER

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)