Z-1719-2025Class II

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

Name: Z-1719-2025 Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-03-24
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-03-24 / Open, Classified / root cause: labeling and UDI

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830 on 2025-03-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1719-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-24
Posted: 2025-05-02
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Product code: MHI Giardia Spp.
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
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].
Quantity in commerce: 56 boxes
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 00742860100017; Lot Number: 08241275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1719-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1719-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-02

Product code MHI

K983399Class IIGiardia/cryptosporidium Combo Rapid AssayGenzyme Diagnostics / cleared 1999-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)