Class 2 Device Recall BD 7Color Setup Beads

• Date Initiated by Firm: June 03, 2025
• Date Posted: July 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2078-2025
• Recall Event ID: 96922
• 510(K)Number: K040026
• Product Classification: Counter, differential cell - Product Code GKZ
• Product: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
• Code Information: Lot # 85612 & 85613/ UDI: 382903357758
• FEI Number: 3027394506
• Recalling Firm/ Manufacturer: Becton, Dickinson and Company, BD Bio Sciences; 155 N Mccarthy Blvd; Milpitas CA 95035-5102
• For Additional Information Contact: North American Regional Complaint Center; 1844-823-5433
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 590 units
• Distribution: US: Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Hong Kong, India, Japan, South Korea, Mexico, Malaysia, Nepal, New Zealand, Peru, Pakistan, Singapore, El Salvador, Taiwan OUS:
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GKZ