Devices

Device Recall Binax

Model / Serial
Lot # 015168 and 015172
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Product Description
NOW RSV Test || Item Number 430-430, Kit Number 430-00R
Manufacturer
Binax, Inc.
1 Event
- Recall of Device Recall Binax

Manufacturer

Binax, Inc.

Manufacturer Address
Binax, Inc., 217 Read St, Portland ME 04103-3460
Source
USFDA

7 devices with a similar name

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Device Recall Binax

Model / Serial
Lot Number 015187
Distribution
KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Product Description
NOW Filariasis Rapid test for W. bancrofti antigen. (Export use only) || Item Number 620-430, Kit Number 620-000,
Manufacturer
Binax, Inc.

Device Recall Binax

Model / Serial
Lot Number 015001, 015002
Distribution
KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Product Description
NOW Malaria (Export use only) || Item Number 660-430, Kit Number 66005, || Kit Number 660-000
Manufacturer
Binax, Inc.

Device Recall BinaxNOW

Model / Serial
Kit lot Numbers: 023357, 023566, 024629, 024631,
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Japan.
Product Description
BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper
Manufacturer
Binax, Inc. dba IMPD

Device Recall BinaxNOW

Model / Serial
Lot number: 24162
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Japan.
Product Description
BinaxNOW A&B; Kit 10 Test Kit (Japan) || Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper
Manufacturer
Binax, Inc. dba IMPD

Device Recall BinaxNOW

Model / Serial
Kit Lot Numbers: 023378, 023411, 023433, 023616, 024021, 024384, 024479, 024480, 024622 NP Swabs Lot Number: 8995
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Japan.
Product Description
BinaxNOW Influenza A&B; 10 Test KIT || Part Number: 416-110 contains NP Swabs with '8995' labeled on the swab wrapper
Manufacturer
Binax, Inc. dba IMPD

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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