REF: 666289 — Class II medical device recall Z-2079-2025
Ongoing recall by Becton, Dickinson and Company, BD Bio Sciences, reported 2025-07-09, distributed in AR, AZ, CA, CO, CT, DC, DE, FL…. Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accura
| Recall number | Z-2079-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Bio Sciences, Milpitas, CA, United States |
| Recall initiated | 2025-06-03 |
| Classified | 2025-07-03 |
| Reported by FDA | 2025-07-09 |
| Distributed | 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 |
| Countries outside the US | AR, AU, BE, BR, CA, CL, CN, CO, DO, EC, HK, IN, JP, KR, MX, MY, NP, NZ, PE, PK, SG, SV, TW |
| Quantity | 278 units |
| UPC / GTIN / UDI-DI | 00382906662897 |
| Lot numbers | 85637, 85638 |
| Model numbers | 666289 |
Product
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2079-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.