Reported Mar 31, 2021 · Terminated
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in…
Meridian Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023
Is this the product you have?
- The ImmunoCard Mycoplasma EIA detects the presence of IgM to M
- pneumoniae in serum - Product Usageintended to aid in the diagnosis of recent Mycoplasma pneumoniae infection
- Lot codes and dates
- Catalog Number709030
- Lot Number709030M114
- Device Identifier00840733101762
- Amount recalled
- 8 kits
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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