Device product
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
Z-0238-2016
Product summary
- Event
- Event 72395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 kits
- Official record key
device-enforcement:Z-0238-2016
Official wording
Reason: Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Code information: 26341, 27011
Distribution pattern: Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Derived failure modes
-
Unknown
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.