BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Brand
Becton, Dickinson and Company, BD Bio Sciences
Lot Codes / Batch Numbers
Lot # 85637 & 85638/ UDI: 382906662897
Products Sold
Lot # 85637 & 85638/ UDI: 382906662897
Becton, Dickinson and Company, BD Bio Sciences is recalling REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescenc due to Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrum. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, NE, NV, NJ, NY, NC, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WV, WI, DC, PR
Page updated: Jan 10, 2026