Alere Scarborough, Inc D/B/A Binax, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
Alere Binaxnow Influenza A & B Card Ref K133411
Regimes: 510(k) Registry: 510(k)Alere I Influenza A & B Ref K141520
Regimes: 510(k) Registry: 510(k)Alere Influenza A & B Test Ref K133637
Regimes: 510(k) Registry: 510(k)Clearview Exact Ii Influenza A & B Test Ref K103610
Regimes: 510(k) Registry: 510(k)
FDA recalls
2015
- 26 Jun 2015 Z-2095-2015 Class II Terminated Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
- 22 Apr 2015 Z-1677-2015 Class II Terminated High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.
Full distribution text
Frequently asked questions
How many devices does Alere Scarborough, Inc D/B/A Binax, Inc. have in the registry?
The registry currently lists 4 devices for Alere Scarborough, Inc D/B/A Binax, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alere Scarborough, Inc D/B/A Binax, Inc.'s devices?
Among its 4 most recently registered devices, Alere Scarborough, Inc D/B/A Binax, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Alere Scarborough, Inc D/B/A Binax, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Alere Scarborough, Inc D/B/A Binax, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Alere Scarborough, Inc D/B/A Binax, Inc.?
FDA recall records list 2 recalls initiated by Alere Scarborough, Inc D/B/A Binax, Inc., the most recent initiated on 26 Jun 2015. 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 Alere Scarborough, Inc D/B/A Binax, Inc. in the registry?
The most recently registered devices listed for Alere Scarborough, Inc D/B/A Binax, Inc. include ALERE BINAXNOW INFLUENZA A & B CARD, ALERE I INFLUENZA A & B, ALERE INFLUENZA A & B TEST and CLEARVIEW EXACT II INFLUENZA A & B TEST.