FDA-Device2015-11-18Class II
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Focus Diagnostics Inc
Hazard
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Sold states
Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Affected count
38 kits
Manufactured in
11331 Valley View St, N/A, Cypress, CA, United States
Products
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2016Don't want to check this manually?
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