FDA Recall Open, Classified

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

Recall: Z-1719-2025 · Initiated March 24, 2025

Recall

Recall Number
Z-1719-2025
Event Number
96662
Firm
MEDLINE INDUSTRIES, LP Northfield
FEI Number
1417592
Product Code
MHI
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
March 24, 2025
Posted
May 2, 2025
Address
3 Lakes Dr, Northfield, IL, 60093-2753

Description

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

Reason

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.

Action

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 [email protected].

Distribution

US Nationwide distribution.

Quantity

56 boxes