CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M recalled
Meridian Bioscience is recalling The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum, distributed nationwide in the US. The recall was initiated on 8 Feb 2021 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-1299-2021
- FDA event ID
- 87430
- Recalling firm
- Meridian Bioscience, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2021
- FDA classified
- 24 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Feb 2021 | Recall initiated by company | |
| 24 Mar 2021 | Classified by FDA | +44 days |
| 31 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of OH, SC.
Questions about this recall
Why was it 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.
Which lots are affected?
Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
Where was it sold?
US Nationwide distribution in the states of OH, SC.
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 26 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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