The ImmunoCard Mycoplasma EIA detects the presence of IgM… recallZ-1299-2021 · Meridian Bioscience Inc · initiated Feb 8, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Meridian Bioscience Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Storage
What the company is doing
On 02/19/2021, Meridian issued an Urgent Medical Device Correction notice to customers via letter for ImmunoCard Mycoplasma kits from a specified lot. Upon receipt at the Cardinal Health Charlotte distribution center, the kits were identified to have a transit time of 115 hours with a maximum temperature of 55 F (approximately 12 C). This is beyond our transit time requirement of 72 hours and storage at 2-8 C. Cardinal placed the kits into a quarantine location, however 8 kits were inadvertently shipped to your facility.
Recall details
- Recall number
- Z-1299-2021
- Status
- Terminated
- Initiated by the company
- Feb 8, 2021
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 8 kits
- Product code
- LJZ
- FDA submissions
- K934550
- Distribution
- US Nationwide distribution in the states of OH, SC.
Product 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.
Code information (models, lots, serial numbers)
Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ImmunoCard Mycoplasma 709030Meridian Bioscience, Inc. · Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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