Vital Scientific N.V.
Country not established
- Devices
- 5
- FDA recalls
- 8
At a glance
Market reach
- United States
- FDA recalls
What Vital Scientific N.V. makes
Vital Scientific N.V. manufactures coagulation testing devices and reagents, including automated analyzers like the Vitalab Flexor, Selectra 2, and Viva for laboratory use, as well as point-of-care coagulation analyzers such as the FIBRON series and QUIKCOAG. Their portfolio also includes reagents for prothrombin time (PT) with calcium, activated partial thromboplastin time (APTT), and coagulation control panels (Level 1, 2, and 3) to monitor clotting function.
The company’s coagulation testing devices and reagents are classified under FDA’s Class I and Class II categories, with relevant products listed via the 510(k) pathway. These products are intended for use in clinical laboratories and point-of-care settings, adhering to regulatory standards for in vitro diagnostics in the United States.
Catalogue
Fibron-1, Fibron-4, Quikcoag, Fibron Ref K021976
510(k) 510(k)Vital Scientific Aptt, Aptt & Quikcoag Aptt Ref K022021
510(k) 510(k)Vital Scientific Coagulation Control, Coagulation Control Level 1, 2, 3, Quikcoag Coagulation Control Ref K022046
510(k) 510(k)Vital Scientific Pt With Calcium Ref K020840
510(k) 510(k)Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva Ref K973628
510(k) 510(k)
FDA recalls
FDA recall records list 8 recalls initiated by Vital Scientific N.V., the earliest on 2012-01-10 and the most recent on 2018-11-15. By recorded status: 2 ongoing and 6 terminated. The reasons filed fall into these groups: software or firmware and electrical or power. 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 2
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 15 Nov 2018 Z-0547-2020 Class II Open since 2018 During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and patient ID mismatch. If not detected, this may lead to an incorrect patient report.
- 7 Sep 2018 Z-0038-2020 Class II Terminated The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If for some reason the cooling of the reagent rotor fails, the reagent cooling indicator light will not illuminate and the acoustic beeper will not go off. As a consequence the operator will not be warned and the reagent storage conditions may fall out of specification.
2016
- 18 Jan 2016 Z-2558-2019 Class II Open since 2016 Instrument stopped working due to a software lockup, and no patient results are produced.
2012
- 10 Jan 2012 Z-0154-2020 Class II Terminated The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 10 Jan 2012 Z-0155-2020 Class II Terminated The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 10 Jan 2012 Z-0156-2020 Class II Terminated The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 10 Jan 2012 Z-0157-2020 Class II Terminated The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- 10 Jan 2012 Z-0158-2020 Class II Terminated The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
Frequently asked questions
How many devices does Vital Scientific N.V. have in the registry?
The registry currently lists 5 devices for Vital Scientific N.V.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vital Scientific N.V.'s devices?
Among its 5 most recently registered devices, Vital Scientific N.V. has devices listed in FDA 510(k) (5 devices).
What risk classes do Vital Scientific N.V.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Vital Scientific N.V.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vital Scientific N.V.?
FDA recall records list 8 recalls initiated by Vital Scientific N.V., the most recent initiated on 2018-11-15. 2 of them are 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 Vital Scientific N.V. in the registry?
The most recently registered devices listed for Vital Scientific N.V. include FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON, VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT, VITAL SCIENTIFIC COAGULATION CONTROL, COAGULATION CONTROL LEVEL 1, 2, 3, QUIKCOAG COAGULATION CONTROL and VITAL SCIENTIFIC PT WITH CALCIUM.