Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits Recalled
One lot of Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830) was stored at improper temperatures in Medline warehouses. The test kits may not perform as intended due to storage outside labeled requirements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text states the product was stored outside labeled requirements with potential impact on performance, but does not report any illnesses, injuries, or confirmed adverse events. The hazard is a precautionary concern about device functionality due to storage conditions.
Plain-English summary
Medline Industries, LP is recalling a single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit, Model Number 750830 (Lot Number: 08241275) distributed nationwide across the United States.
The test kits were inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements. This improper storage may affect the test kit's ability to perform as intended.
Patients or healthcare providers who have this product in use should contact the manufacturer for guidance. The affected lot can be identified by Lot Number 08241275 (UDI-DI: 00742860100017).
The recalled product
- Product
- Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 56
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00742860100017
- Lot Number: 08241275
Distribution
Distributed nationwide across the United States.
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