Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The ImmunoCard Mycoplasma EIA detects the presence of IgM to Recalled by Meridian Bioscience Inc Due to Use of the kits after incorrect storage could...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Meridian Bioscience Inc directly.
Affected Products
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
Quantity: 8 kits
Why Was This Recalled?
Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Meridian Bioscience Inc
Meridian Bioscience Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report