MEDLINE INDUSTRIES, LP - Northfield recalls Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits

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.

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

An URGENT MEDICAL DEVICE RECALL notification letter dated 3/24/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-063 Recall Code: Recall Code 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers return any affected product to you for collection and return to Medline Industries, LP. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

• FDA enforcement recordOfficial FDA database entry for Z-1719-2025
• FDA 510(k) clearance · K983399The device's official FDA premarket clearance record
• FDA device classification · MHIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.3220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.