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.
Action Details
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
Distribution Pattern
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
Code Information / Serial Numbers
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.