Clark Laboratories, Inc. recalls Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of…

Recall date

March 17, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1503-2021

FDA classification

Class II

Brand / firm

Clark Laboratories, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution and the country of Ireland.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.