FDA Medical devices recall ·
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits… recall
- Recall number
- Z-1719-2025
- Date
- (initiated March 24, 2025)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 56 boxes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00742860100017; Lot Number: 08241275
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1719-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.