Recall Z-0238-2016 ยท OTT Research Use Only/Microbiology
Focus Diagnostics Inc
Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
| Date | Nov 6, 2015 (initiated Oct 2, 2015) |
| Status | Terminated |
| Reason | Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results. |
| Root cause | Device Design |
| Action | A recall letter dated 10/2/15 was sent to distributors who distributed the Anaplasma phagocytophilum IFA IgM (IF1450M) kit lots 26431 and 27011. The letter informs the customers that Focus Diagnostics received customer complaints of IF1450M with low reactivity, which may result in higher invalid rate. The letter also provides the customers with Focus Diagnostics' recommendations and actions to be taken by the distributors. Customers with questions or require additional information are instructed to contact Focus Diagnostics' Technical Services department at (562) 240-6550 from 7am to 5pm (PS |
| Quantity | 38 kits |
| Distribution | Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.