Meridian Crypto/Giardia Test Kits recalled due to improper temperature storage
Medline Industries is recalling one lot of Meridian ImmunoCard STAT! Crypto/Giardia Test Kits due to improper temperature storage. The affected lot was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II diagnostic test kit recall with documented improper storage affecting product reliability. Classified as High (Score 3) per rubric criterion for risk-of-harm products where no illnesses or injuries have been reported but performance integrity is compromised.
Plain-English summary
Medline Industries, LP is recalling Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits (Model 750830). One lot (08241275) was inadvertently stored at temperatures outside the manufacturer's labeled storage requirements. This lot, distributed as 56 boxes nationwide in the United States, is being recalled.
Proper storage is required to maintain test kit reliability and performance. Diagnostic test kits stored outside recommended temperature conditions may not function as intended, potentially affecting test accuracy.
Healthcare facilities and laboratories that received test kits from this lot should discontinue use and contact Medline Industries for replacement or refund. No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- improper-storage
- test-inaccuracy
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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