Ams Diagnostics
Country not established
- Devices
- 1
- FDA recalls
- 40 ongoing since 2021 (1 open in total)
At a glance
Market reach
- United States
- FDA recalls
What Ams Diagnostics makes
Ams Diagnostics manufactures the LIASYS 600 Electrolyte Measurement System, a laboratory device for analyzing electrolyte levels and creatinine, along with compatible reagents designed for use with the system.
The company’s products fall under FDA Class II regulation and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Ams Diagnostics, the earliest on 2014-02-11 and the most recent on 2016-02-29. By recorded status: 1 ongoing and 3 terminated. The reasons filed fall into these groups: 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.
2016
- 29 Feb 2016 Z-2725-2017 Class III Open since 2016 Lot was not functioning properly and not exhibiting the correct physical properties.
2014
- 11 Feb 2014 Z-1267-2014 Class II Terminated Marketing the devices outside 510(k) requirements
- 11 Feb 2014 Z-1268-2014 Class II Terminated Marketing the devices outside 510(k) requirements
- 11 Feb 2014 Z-1269-2014 Class II Terminated Marketing the devices outside 510(k) requirements
Frequently asked questions
How many devices does Ams Diagnostics have in the registry?
The registry currently lists 1 device for Ams Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ams Diagnostics's devices?
Among its 1 most recently registered device, Ams Diagnostics has devices listed in FDA 510(k) (1 device).
What risk classes do Ams Diagnostics's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ams Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Ams Diagnostics?
FDA recall records list 4 recalls initiated by Ams Diagnostics, the most recent initiated on 29 Feb 2016. 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 Ams Diagnostics in the registry?
The most recently registered devices listed for Ams Diagnostics include LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600.