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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Meridian Bioscience ImmunoCard STAT! Test Kits Recalled for Temperature Error

Agency Publication Date: May 2, 2025
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Summary

Medline Industries is recalling 56 boxes of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830). These kits were inadvertently stored in warehouses at temperatures outside of the required storage requirements. Using kits stored at incorrect temperatures can lead to unreliable diagnostic results when testing for parasites like Cryptosporidium and Giardia. No injuries or incidents have been reported to date.

Risk

Incorrect storage temperatures can degrade the chemical components of the test kit, potentially causing inaccurate or false results. This could lead to a patient being misdiagnosed or receiving delayed medical treatment for a parasitic infection.

What You Should Do

  1. The recalled products are Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830, with Lot Number 08241275 and UDI-DI 00742860100017.
  2. Stop using the recalled product immediately to prevent potential diagnostic errors.
  3. Contact Medline Industries, LP or your distributor to arrange for the return, replacement, or correction of the affected test kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits
Model / REF:
750830
Lot Numbers:
08241275
UDI:
00742860100017

56 boxes affected; stored outside labeled storage requirements.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96662
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Medline warehouses
Manufactured In: United States
Units Affected: 56 boxes
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.