DxFLEX Flow Cytometer recall: Software Issue
DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device…
Why was DxFLEX Flow Cytometer 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: C78500 UDI-DI code: 15099590754013 Serial Numbers: BH44060, BJ09004, BJ14015, BJ09010, BJ13012, BJ14014, BJ13011, BJ14017, BJ13013, BJ09003, BJ09008, BJ09009, BH39057, BH44059, BJ14016, BJ05002, BJ17020, BJ17021, BH26031, BJ19024, BJ09005, BJ09006, BJ09007, BJ19022, BJ19023
- 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…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 25 units
- Distribution
- Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.
- Recall date
- November 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)