Device Recall Binax

  • Model / Serial
    Lot # 015168 and 015172
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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

7 devices with a similar name

Learn more about the data here

  • 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
  • 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
  • Model / Serial
    Kit lot Numbers: 023357, 023566, 024629, 024631,
  • Product Classification
  • 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
  • Model / Serial
    Lot number: 24162
  • Product Classification
  • 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
  • Model / Serial
    Kit Lot Numbers: 023378, 023411, 023433, 023616, 024021, 024384, 024479, 024480, 024622 NP Swabs Lot Number: 8995
  • Product Classification
  • 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
2 more