Catch Incorporated
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Catch Incorporated makes
Catch Incorporated makes a liquid stable 2-part homocysteine reagent.
This device is classified as Class II and is listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Liquid Stable (Ls) 2-Part Homocysteine Reagent Ref K062808
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Catch Incorporated, the earliest on 2007-01-18 and the most recent on 2011-06-27. By recorded status: 2 terminated. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 27 Jun 2011 Z-0921-2012 Unclassified (pre-2012) Terminated Homogeneous Enzymic Homocysteine Reagent Two Part Reagent Method will not calibrate due to Reagent R1 had prematurely decayed.
2007
- 18 Jan 2007 Z-0448-2009 Unclassified (pre-2012) Terminated A high homocysteine level can be reported as falsely low.
Frequently asked questions
How many devices does Catch Incorporated have in the registry?
The registry currently lists 1 device for Catch Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catch Incorporated's devices?
Among its 1 most recently registered device, Catch Incorporated has devices listed in FDA 510(k) (1 device).
What risk classes do Catch Incorporated's devices fall under?
Among its 1 most recently registered device, the classes recorded for Catch Incorporated's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Catch Incorporated?
FDA recall records list 2 recalls initiated by Catch Incorporated, the most recent initiated on 27 Jun 2011. 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 Catch Incorporated in the registry?
The most recently registered devices listed for Catch Incorporated include LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT.