CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits recalled
MEDLINE INDUSTRIES, LP - Northfield is recalling Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, distributed nationwide in the US. The recall was initiated on 24 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1719-2025
- FDA event ID
- 96662
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2025
- FDA classified
- 2 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Mar 2025 | Recall initiated by company | |
| 2 May 2025 | Classified by FDA | +39 days |
| 14 May 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits recalled?
Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits on 24 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1719-2025.
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.
Which lots are affected?
UDI-DI: 00742860100017; Lot Number: 08241275
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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