Focus Diagnostics Inc recalls Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

Recalled November 18, 2015 · FDA recall Z-0238-2016 · Focus Diagnostics

Hazard

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results. · FDA Class II

Units

38 kits

Sold at

Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia

Description

Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.

Product

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.

Manufacturer(s)

Focus Diagnostics Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →