Home / Recalls / Clark Laboratories, Inc. / Z-1503-2021

Z-1503-2021 Class II Terminated

Recalled by Clark Laboratories, Inc. — Jamestown, NY

Recall Details

Product Type: Devices
Report Date: May 5, 2021
Initiation Date: March 17, 2021
Termination Date: June 29, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80 kits

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

Code Information

Kit Lot: 2326060-060 Expiration Date: 2021-06-28 (UDI): 05391516743655