FDA recall Z-1503-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-03-17

Report date

2021-05-05

Termination date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jamestown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1503-2021