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Recall Observatory FDA recall evidence

Device product

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

Z-1719-2025

March 24, 2025

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 96662
Status
Ongoing
Classification
Class II
Quantity
56 boxes
Official record key
device-enforcement:Z-1719-2025

Official wording

Reason: 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.

Code information: UDI-DI: 00742860100017; Lot Number: 08241275

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.