Clinical Diagnostic Systems, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Kodak Ektacchem 950IRC Analyzer Ref K946090
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 11 Jan 2018 Z-1322-2018 Class III Terminated VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
Full distribution text
- 11 Jan 2018 Z-1322-2018 Class III Terminated VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected frequency of customer generated calibration curves to fall outside of the calibration quality parameter measuring the gradient of the Customer Calibration Curve between Calibrator Level 2 and Calibrator Level 3.
Frequently asked questions
How many devices does Clinical Diagnostic Systems, Inc. have in the registry?
The registry currently lists 1 device for Clinical Diagnostic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clinical Diagnostic Systems, Inc.'s devices?
Among its 1 most recently registered device, Clinical Diagnostic Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Clinical Diagnostic Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Clinical Diagnostic Systems, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for Clinical Diagnostic Systems, Inc.?
FDA recall records list 1 recall initiated by Clinical Diagnostic Systems, Inc., the most recent initiated on 11 Jan 2018. 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 Clinical Diagnostic Systems, Inc. in the registry?
The most recently registered devices listed for Clinical Diagnostic Systems, Inc. include KODAK EKTACCHEM 950IRC ANALYZER.