FDA Device recall Z-1299-2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of re…
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of re… by Meridian Bioscience, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1299-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-08 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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All Meridian Bioscience recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.