Clark Laboratories, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1503-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 17, 2021

Date Posted: May 5, 2021

Recall Number: Z-1503-2021

Event ID: 87637

Reason for Recall:

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

Status: Terminated

Product Quantity: 80 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated