Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3027977508
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. makes
The company produces diagnostic reagents and clinical chemistry analyzers, including immunoglobulin G (IgG) testing kits, ion-selective electrode (ISE) reagents, and assays for glucose and C-reactive protein (CRP) via latex turbidimetry. Its DxC 500 AU analyzer automates biochemical measurements for hospital and laboratory use.
These products are classified as Class II devices under FDA regulations and are supported by 510(k) clearance records. The company is headquartered in the United States with a manufacturing presence in Suzhou, China.
Catalogue
Immunoglobulin G (IgG) Ref K221114
Regimes: 510(k) Registry: 510(k)- Regimes: CE IVDR 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3027977508
- Address
- No.11, Zhensheng Road, Suzhou Industrial Park, Suzhou Jiangsu
FDA recalls
FDA recall records list 1 recall initiated by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., initiated on 2025-01-10. By recorded status: 1 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 10 Jan 2025 Z-1233-2025 Class II Ongoing 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.
Full distribution text
- 10 Jan 2025 Z-1233-2025 Class II Ongoing 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.
Frequently asked questions
How many devices does Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. have in the registry?
The registry currently lists 2 devices for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.'s devices?
Among its 2 most recently registered devices, Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.?
FDA recall records list 1 recall initiated by Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., the most recent initiated on 10 Jan 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. in the registry?
The most recently registered devices listed for Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. include Immunoglobulin G (IgG) and ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer.