What is FDA product code OYE?

To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.

DxFLEX · Flow Cytometric Reagents and Accessories. → Hematology

Name: DxFLEX
Brand: DxFLEX

1manufacturer

1catalogue number

5510(k) clearances naming this product code

7recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code OYE
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Biotechnology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for DxFLEX
Listed by	Beckman Coulter, Inc., United States
FDA product code	OYE
Device type	Flow Cytometric Reagents And Accessories.
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
Record published	2025-09-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for DxFLEX
Catalogue number	Size	Status
C78500		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Navios EX	Beckman Coulter Ireland Inc	7
BD FACSuite	Becton, Dickinson AND Company	5
BD FACSLyric	Becton, Dickinson AND Company	4
FACSCanto	Becton, Dickinson AND Company	4
Navios Analysis Software	Beckman Coulter Ireland Inc	3
FACSuite	Becton, Dickinson AND Company	3
Flow Cytometric Reagents And Accessories.	Becton, Dickinson AND Company	3
BD FACSDiva	Becton, Dickinson AND Company	3
Navios	Beckman Coulter Ireland Inc	3
BD FACSDiva™	Becton, Dickinson AND Company	2
FACSVia	Becton, Dickinson AND Company	2
Navios tetra Software	Beckman Coulter Ireland Inc	1

Showing 12 of 20. All products under Flow Cytometric Reagents And Accessories.

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232600	2023-11-22
K162897	2017-06-23
K141932	2015-04-10
K130373	2013-09-18
K121445	2013-07-26

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of DxFLEX
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Beckman Coulter, Inc.	UDI-DI	2025-09-22	Class II	Under Investigation by firm	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.	25 units

Recalls

6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2018-01-29	Class II	Software design	The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the mis-identification.	288 devices	2019-06-27
2017-10-02	Class II	Software design	The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)	268 units	2019-05-08
2017-08-21	Class II	Under Investigation by firm	Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect va	213 units (34 units in the US)	2023-09-27
2017-04-03	Class II	Other	Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS System software is not correctly exporting Tetra Combo CRD files.	188 units total (24 units in US)	2017-08-07
2016-10-19	Class II	Under Investigation by firm	Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra application. The issue could lead to an increase in	2367 units total (207 units in US)	2017-02-24
2016-09-06	Class II	Software Design Change	Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.	148 units total (12 units in US)	2017-08-07

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

DxFLEX