Inverness Medical Professional Diagnostics-Binax
Country not established
- Devices
- 2
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Inverness Medical Professional Diagnostics-Binax makes
Inverness Medical Professional Diagnostics-Binax manufactures rapid diagnostic tests, including the BINAX NOW MALARIA TEST (models 660-000, 660-XXX), designed for point-of-care detection of malaria in whole blood samples.
The company’s portfolio is regulated under FDA’s Class II device classification, with relevant products listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Binax Now Malaria Test; Model 660-000, 660-Xxx Ref DEN070006
Regimes: De Novo Registry: De Novo
FDA recalls
2010
- 12 Feb 2010 Z-2500-2010 Unclassified (pre-2012) Terminated Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.
- 12 Feb 2010 Z-2501-2010 Unclassified (pre-2012) Terminated Specific lots no longer meet their stated limit of detection claims of 2000 mIU/mL for the UCG-Slide test and 500 mIU/mL for the UCG-Beta Slide Monoclonal II test.
2007
- 15 Feb 2007 Z-0594-2007 Unclassified (pre-2012) Terminated Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.
2006
- 29 Sep 2006 Z-0222-2007 Unclassified (pre-2012) Terminated Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches
Frequently asked questions
How many devices does Inverness Medical Professional Diagnostics-Binax have in the registry?
The registry currently lists 2 devices for Inverness Medical Professional Diagnostics-Binax. Devices recorded under merged duplicate company entries are counted once.
Which registries list Inverness Medical Professional Diagnostics-Binax's devices?
Among its 2 most recently registered devices, Inverness Medical Professional Diagnostics-Binax has devices listed in FDA 510(k) (2 devices).
What risk classes do Inverness Medical Professional Diagnostics-Binax's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Inverness Medical Professional Diagnostics-Binax's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Inverness Medical Professional Diagnostics-Binax?
FDA recall records list 4 recalls initiated by Inverness Medical Professional Diagnostics-Binax, the most recent initiated on 12 Feb 2010. 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 Professional Diagnostics-Binax in the registry?
The most recently registered devices listed for Inverness Medical Professional Diagnostics-Binax include MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000, 852-012 and BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX.