—#213368

Product

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

FDA product code: MHI — Giardia Spp.
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K983399
Affected lot / code info: UDI-DI: 00742860100017; Lot Number: 08241275

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-03-24
Posted by FDA: 2025-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213368. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.