Inverness Medical, Inc.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Inverness Medical, Inc. makes
Inverness Medical, Inc. manufactures the CLEARVIEW EXACT II INFLUENZA A & B TEST, a rapid diagnostic device designed to detect influenza A and B viruses from patient samples.
The device is classified as Class II under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Clearview Exact Ii Influenza A & B Test Ref K092349
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Inverness Medical, Inc., initiated on 2008-10-08. By recorded status: 1 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.
2008
- 8 Oct 2008 Z-1014-2012 Unclassified (pre-2012) Terminated It has come to our attention that users of these product lots may experience an elevation in the rate of false positivity when compared with previous product lots. Internal quality assurance testing has shown that the products are performing within the release specifications, although there has been a slight shift in the cut-off which may lead to an increase in the number of positive results obta
Frequently asked questions
How many devices does Inverness Medical, Inc. have in the registry?
The registry currently lists 1 device for Inverness Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inverness Medical, Inc.'s devices?
Among its 1 most recently registered device, Inverness Medical, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Inverness Medical, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Inverness Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Inverness Medical, Inc.?
FDA recall records list 1 recall initiated by Inverness Medical, Inc., the most recent initiated on 8 Oct 2008. 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 Inverness Medical, Inc. in the registry?
The most recently registered devices listed for Inverness Medical, Inc. include CLEARVIEW EXACT II INFLUENZA A & B TEST.