Arkray Factory USA, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1832816
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 3
What Arkray Factory USA, Inc. makes
The company manufactures blood glucose monitoring systems, including portable devices like the Assure Platinum, GlucoCard X-Meter, and PocketChem EZ, as well as the GlucoCard 01-Mini and Assure Pro models. It also provides diabetes data management software, such as SMBG Viewer and the Ark Care Diabetes Management System, designed to track and analyze glucose readings.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Assure Platinum Blood Glucose Monitoring System Ref K092104
Regimes: 510(k) Registry: 510(k)Arkray Glucocard 01 Blood Monitoring System Ref K073416
Regimes: CE IVDD 510(k) Registry: 510(k)Pocketchem Ez Blood Glucose Monitoring System Ref K090653
Regimes: 510(k) Registry: 510(k)Ark Care Diabetes Managment System Ref K110709
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1832816
- Address
- 8260 NW 27th Street, Miami, FL, 33122
FDA recalls
FDA recall records list 3 recalls initiated by ARKRAY FACTORY USA, INC., the earliest on 2015-12-18 and the most recent on 2019-05-03. By recorded status: 3 terminated. The reasons filed fall into these groups: software or firmware and manufacturing or quality process. 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 1
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2019
- 3 May 2019 Z-1850-2019 Class II Terminated This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.
2015
- 18 Dec 2015 Z-0630-2016 Class I Terminated One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
- 18 Dec 2015 Z-0631-2016 Class I Terminated One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.
Frequently asked questions
How many devices does ARKRAY FACTORY USA, INC. have in the registry?
The registry currently lists 9 devices for ARKRAY FACTORY USA, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ARKRAY FACTORY USA, INC.'s devices?
Among its 9 most recently registered devices, ARKRAY FACTORY USA, INC. has devices listed in FDA 510(k) (9 devices).
What risk classes do ARKRAY FACTORY USA, INC.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for ARKRAY FACTORY USA, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ARKRAY FACTORY USA, INC.?
FDA recall records list 3 recalls initiated by ARKRAY FACTORY USA, INC., the most recent initiated on 3 May 2019. 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 ARKRAY FACTORY USA, INC. in the registry?
The most recently registered devices listed for ARKRAY FACTORY USA, INC. include ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS, ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER), GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 and ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001.