DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code:… — Class II medical device recall Z-0541-2026
Ongoing recall by Beckman Coulter Inc., reported 2025-11-26, distributed nationwide. Due to a software error code that crashes during acquisition on patient sample when running customer defined a
| Recall number | Z-0541-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2025-09-22 |
| Classified | 2025-11-18 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN |
| Quantity | 25 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15099590754013 |
| Serial numbers | BH26031, BH39057, BH44059, BH44060, BJ05002, BJ09003, BJ09004, BJ09005, BJ09006, BJ09007, BJ09008, BJ09009, BJ09010, BJ13011, BJ13012, BJ13013, BJ14014, BJ14015, BJ14016, BJ14017, BJ17020, BJ17021, BJ19022, BJ19023, BJ19024 |
| Model numbers | C78500 |
Product
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.
Reason for recall
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
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-0541-2026. 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.