BD FACS Sample Prep Assistant — Class II medical device recall Z-2357-2020
Terminated recall by Becton, Dickinson and Company, BD Biosciences, reported 2020-06-17, distributed nationwide. The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to re
| Recall number | Z-2357-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, BD Biosciences, San Jose, CA, United States |
| Recall initiated | 2019-07-08 |
| Classified | 2020-06-11 |
| Reported by FDA | 2020-06-17 |
| Terminated | 2023-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, CL, CN, CO, CR, HK, IN, IT, JM, JP, KR, MX, MY, NI, NZ, PE, RO, RU, SG, TR, VN, ZA |
| Quantity | 51 units |
| Model numbers | 650686BD |
Product
BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.
Reason for recall
The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.
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-2357-2020. 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.