Reported Nov 26, 2025 · Ongoing
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- DxFLEX Flow Cytometer
- Catalog Number C78500 UDI-DI code15099590754013 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
- Lot codes and dates
- Catalog NumberC78500
- UDI-DI code15099590754013
- Serial Numbers
BH44060BJ09004BJ14015BJ09010BJ13012BJ14014BJ13011BJ14017BJ13013BJ09003BJ09008BJ09009BH39057BH44059BJ14016BJ05002BJ17020BJ17021BH26031BJ19024BJ09005BJ09006BJ09007BJ19022BJ19023
- Amount recalled
- 25 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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