FDA Medical Device Recalls (openFDA)
Becton, Dickinson and Company, BD Bio Sciences: REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
- Recall number
- Z-2078-2025
- Recalling firm
- Becton, Dickinson and Company, BD Bio Sciences
- Product
- REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
- Status
- Open, Classified
- Initiated
- 2025-06-03
- Posted
- 2025-07-03
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 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:
- Lot, serial or model codes
- Lot # 85612 & 85613/ UDI: 382903357758
- 510(k) numbers
- ["K040026"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 3027394506
- Firm city
- Milpitas
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28