Organon Teknika Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 136
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Search and filter all 136 devicesShowing 1-50 of 136
FDA recalls
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
- 11 Jan 2019 Z-0962-2019 Class II Terminated This notice has been initiated due to potential for compromised test card Top Seal Integrity which could: - yield false resistance for antibiotics on the AST panel - cause a false negative ESBL Test - result in a false positive urea (URE) reaction on ID cards
Frequently asked questions
How many devices does Organon Teknika Corp. have in the registry?
The registry currently lists 136 devices for Organon Teknika Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Organon Teknika Corp.'s devices?
Among its 50 most recently registered devices, Organon Teknika Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Organon Teknika Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Organon Teknika Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Organon Teknika Corp.?
FDA recall records list 1 recall initiated by Organon Teknika Corp., the most recent initiated on 2019-01-11. 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 Organon Teknika Corp. in the registry?
The most recently registered devices listed for Organon Teknika Corp. include FIBRINOSTIKA TDP MICROELISA SYSTEM, NEPHROSS I.Q. ANDANTE, MDA PROTEIN ASSAY and BSM 2000 DIALYSIS MACHINE.