Focus Diagnostics Inc recalls Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
- Recall date
- October 2, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0238-2016
- FDA classification
- Class II
- Brand / firm
- Focus Diagnostics Inc
- Sold / distributed
- Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Why it was recalled
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
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