FDA Device recall Z-2078-2025
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation by Becton Dickinson And Bd Bio Sciences, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2078-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-03 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And Bd Bio Sciences |
| Distribution | AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WI, WV |
Product
REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
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.
Identifiers
| code_info | Lot # 85612 & 85613/ UDI: 382903357758 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2078-2025%22
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