The ImmunoCard Mycoplasma EIA detects the presence of IgM to M — Class II medical device recall Z-1299-2021
Terminated recall by Meridian Bioscience Inc, reported 2021-03-31, distributed nationwide. Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the eve
| Recall number | Z-1299-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meridian Bioscience Inc, Cincinnati, OH, United States |
| Recall initiated | 2021-02-08 |
| Classified | 2021-03-24 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2021-10-26 |
| Distributed | Nationwide (US) |
| Quantity | 8 kits |
| UPC / GTIN / UDI-DI | 00840733101762 |
| Lot numbers | 709030M114 |
| Model numbers | 709030 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1299-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.