Class II — Potential Health Hazard

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

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) Recalled by Euro Diagnostica AB Due to Decreasing performance overtime.

Date: February 14, 2016
Company: Euro Diagnostica AB
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 Euro Diagnostica AB directly.

Affected Products

Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.

Quantity: 25 kits (US only)

Why Was This Recalled?

Decreasing performance overtime.

Where Was This Sold?

Minnesota and Texas Foreign: Iran

About Euro Diagnostica AB

Euro Diagnostica AB has 8 total recalls tracked by RecallDetector.

Related Recalls

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