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.

BD FACSLyric · Flow Cytometric Reagents and Accessories. → Hematology

Name: BD FACSLyric
Brand: BD FACSLyric

1manufacturer

4catalogue numbers in this listing

2510(k) clearances naming this product 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 BD FACSLyric
Listed by	Becton, Dickinson AND Company, 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, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
Record published	2017-09-27
Record revised	2024-10-22 (version 7)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number
Storage	Special storage condition: Room Temperature

Catalogue Numbers

Catalogue numbers for BD FACSLyric
Catalogue number	Size	Status
662878		In distribution
662877		In distribution
662875		In distribution
662876		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
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
DxFLEX	Beckman Coulter, 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
K201814	2020-09-28
K170974	2017-07-03

Recalls Naming This Product

5 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of BD FACSLyric
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2024-11-01	Class II	Nonconforming Material/Component	On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, whic	15 power supplies
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2024-11-01	Class II	Nonconforming Material/Component	On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, whic	20 power supplies
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2024-11-01	Class II	Nonconforming Material/Component	On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, whic	16 power supplies
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2024-11-01	Class II	Nonconforming Material/Component	On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, whic	49 power supplies
Becton, Dickinson and Company, BD Biosciences	UDI-DI	2019-01-02	Class III	Under Investigation by firm	A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is not a released configuration for clinical use. It i	3 devices	2021-05-07

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.

BD FACSLyric