Who else makes this device?

Name: Automated Hematology Analyzer XN-L series XN-430
Brand: Automated Hematology Analyzer XN-L series XN-430

Hematology › Automated Hematology DevicesCounter, Differential Cell

Automated Hematology Analyzer XN-L Series XN-430

Catalogue number CL032175, listed by Sysmex Corporation, Japan, under Counter, Differential Cell. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

4510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GKZ
Manufacturer	City	Province	Registered as	Device types
VTech Communications Ltd	Dongguan	Guangdong	Contract manufacturer	5
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
Onechipdx Biotech (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Specification developer	2

Record

Regulatory record for Automated Hematology Analyzer XN-L series XN-430
Listed by	Sysmex Corporation, Japan
FDA product code	GKZ
Device type	Counter, Differential Cell
Device class	Class 2
Regulation	21 CFR 864.5220
Establishment	Manufacturer, Exporter
Record published	2017-06-05
Record revised	2024-05-16 (version 7)

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 Automated Hematology Analyzer XN-L series XN-430
Catalogue number	Size	Status
CL032175		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
QBC Diagnostics	Drucker Diagnostics, LLC	41
Cell-DYN	Abbott Laboratories	19
Research and Diagnostic Systems	Research AND Diagnostic Systems, Inc.	17
Simultest	Becton, Dickinson AND Company	10
BD FACSCanto™	Becton, Dickinson AND Company	10
FACSCanto	Becton, Dickinson AND Company	7
BD Multitest	Becton, Dickinson AND Company	6
Coulter AcT	Beckman Coulter, Inc.	6
BD™ Multi-Check	Becton, Dickinson AND Company	6
BD Tritest	Becton, Dickinson AND Company	6
Coulter LH	Beckman Coulter, Inc.	5
HemoScreen	Pixcell Medical Inc.	5

Showing 12 of 245. All products under Counter, Differential Cell

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K992875	1999-11-09
K971736	1997-08-26
K945837	1995-06-09
K943894	1995-02-03

Recalls

1 of these is 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
2014-12-18	Class II	Device Design	There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.	1,137 units (US) 54 units (Canada) 9 inventory	2016-07-25

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.