FDA recall Z-1719-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830

Reason for recall

A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-03-24
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1719-2025