Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit Recalled by Focus Diagnostics Inc Due to Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA...

Date: October 2, 2015
Company: Focus Diagnostics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Focus Diagnostics Inc directly.

Affected Products

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

Quantity: 38 kits

Why Was This Recalled?

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

Where Was This Sold?

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

About Focus Diagnostics Inc

Focus Diagnostics Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report