CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report

DxFLEX Flow Cytometer recalled by Beckman Coulter

Beckman Coulter is recalling DxFLEX Flow Cytometer, distributed nationwide in the US. The recall was initiated on 22 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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

Quantity recalled25 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0541-2026
FDA event ID: 97624
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Sep 2025
FDA classified: 18 Nov 2025
Reported: 26 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Test Kits & Diagnostics

Timeline

22 Sep 2025	Recall initiated by company
18 Nov 2025	Classified by FDA	+57 days
26 Nov 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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.

Where it was distributed

Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.

Nationwide California Connecticut Florida Illinois New York Ohio Oregon Tennessee Texas

Questions about this recall

Is DxFLEX Flow Cytometer recalled?

Yes. Beckman Coulter recalled DxFLEX Flow Cytometer on 22 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0541-2026.

Why was it 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.

Which lots 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

Where was it sold?

Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY, OH, OR, TN, and TX. The country of India.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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