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

FDA device recall Z-0238-2016 · posted 2015-11-06 · Terminated

Recall details

Recalling firm

Focus Diagnostics Inc

Reason for recall

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

Action taken

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 DxTS@focusdx.com.

Root cause

Device Design

Status

Terminated

Product code

OTT

Quantity affected

38 kits

Distribution

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

Date initiated

2015-10-02

Date posted

2015-11-06

Date terminated

2016-01-29

Location

Cypress, CA