Devices

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
1 Event
- Recall of Device Recall BinaxNOW

Manufacturer

Binax, Inc. dba IMPD

Manufacturer Address
Binax, Inc. dba IMPD, 10 Southgate Rd, Scarborough ME 04074-8303
Source
USFDA

4 devices with a similar name

Learn more about the data here

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:024020, 024175, 024360, 024361, 024385, 024596, 024597, 024703, 024705, 024704, 024714, 024715, 024718, 024726, 025087 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; 22 Test Kit || Part Number: 416-022, contains NP Swabs with '8995' labeled on the swab wrapper
Manufacturer
Binax, Inc. dba IMPD

Device Recall BinaxNOW

Model / Serial
Kit Lot Numbers: 023437, 024056, 024057, 024436, 024516, 024518, 024694, 024695, 024882, 025090, 025089 NP Swabs Lot Number: 8995
Product Classification
Immunology and Microbiology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Japan.
Product Description
BinaxNOW RSV 10 Test Kit || Part Number : 430-100, 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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