Class II — Potential Health Hazard

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

Trinity Biotech Captia Measles IgM Kit Recalled by Clark Laboratories, Inc. Due to Positive Control may run high out of its...

Date: March 17, 2021
Company: Clark Laboratories, 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 Clark Laboratories, Inc. directly.

Affected Products

Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection.

Quantity: 80 kits

Why Was This Recalled?

Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Clark Laboratories, Inc.

Clark Laboratories, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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