Meridian Bioscience Inc Recall 87430
Description: 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.
Meridian Bioscience Inc Recall 87430 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1299-2021 |
| Event ID | 87430 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of OH, SC. |
| Quantity | 8 kits |
| Recall Reason | 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 Classification | 20210331 |
| Device Code Info | Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762. |
| Center Classification Date | 20210324 |
| Recall Initiation Date | 20210208 |
| Recalling Firm | Meridian Bioscience Inc |
| Initial Notification | Letter |
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