Recall Z-0009-2025 ยท PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
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.
| Date | Oct 3, 2024 (initiated Aug 12, 2024) |
| Status | Open, Classified |
| 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 t |
| 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, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.