Becton, Dickinson And Company, BD Bio Sciences recalls REF: 335775

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

On June 3, 2025, Becton, Dickinson issued a "Urgent: Medical Device Recall Correction" Notification to affected customers via mail and E-Mail. BD asked consignees to take the following action: 1: Immediately inspect your inventory for the specific catalog and lot numbers listed. It is recommended that the clinical laboratory staff review and segregate the affected lots. 2. Remove and discard prior affected label insert with incorrect spectral overlap factor values included on kit box prior to use. 3. The wrong SOF (Spectral Over Factors) values can be corrected by entering the right SOF values provided in Table 1. 4. Ensure the right SOF values are entered in the flow cytometry instrument prior to sample acquisition. 5. Customers who have not used the affected product may proceed to enter the SOF values. 6. If the affected products have been fully or partially used and subjects' samples have been processed and acquired on an instrument with the incorrect SOF values, please review the results. 7. If the subject sample(s) is not available anymore, this may require the subject to return to collect an additional sample for testing purposes. 8. Ensure the contents of this Product Recall Notification are read and understood. 9. Share and post this customer letter with the users of this application at your facility and forward to any customers to whom you may have distributed the product to ensure awareness.

• FDA enforcement recordOfficial FDA database entry for Z-2078-2025
• FDA 510(k) clearance · K040026The device's official FDA premarket clearance record
• FDA device classification · GKZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.5220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Becton, Dickinson and Company, BD Bio SciencesSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.