Recall Z-2078-2025 ยท GKZ Counter, Differential Cell
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.
| Date | Jul 3, 2025 (initiated Jun 3, 2025) |
| Status | Open, Classified |
| 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 val |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040026 | BD FACS 7-COLOR SETUP BEADS Becton Dickinson Immunocytometry Systems, Sep 10, 2004 |