Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.

Suzhou Jiangsu, CN

BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. appears in FDA device records in Suzhou Jiangsu, CN. FDA records list 2 510(k) clearances between 2023-07-20 and 2023-08-02, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. in 2023.

Clearances by year, as a table

510(k) clearance decisions for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., by decision year
Year	Clearances
2023	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K221114	Immunoglobulin G (IgG)	CFN	Substantially Equivalent	2023-08-02
K220977	ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer	JGS	Substantially Equivalent	2023-07-20

Registered establishments

FDA registered establishments for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3027977508	3027977508	BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.	No.11, Zhensheng Road, Suzhou Industrial Park, Suzhou Jiangsu 215126 CN	2026	JIT JJE JKD JQX

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1233-2025	DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.	Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.	Class II	2025-01-10	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain