BD FACSDuet Premium Sample Preparation System recall: Software Issue
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with…
Why was BD FACSDuet Premium Sample Preparation System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with…
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- 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
- Recall date
- October 9, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)