Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
FDA Recall Z-0238-2016 · Posted 2015-11-06
Recalling FirmFocus Diagnostics Inc
Recall StatusTerminated
Product CodeOTT
Date Initiated2015-10-02
Date Terminated2016-01-29
Product Quantity38 kits
Reason for Recall
Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results.
Firm 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 (PST) or send an email to [email protected].
Root Cause
Device Design
Distribution Pattern
Non US (worldwide): Czech Republic, Denmark, Germany, Italy, Spain and Colombia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.