The ImmunoCard Mycoplasma EIA detects the presence of recall
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent…
Why was The ImmunoCard Mycoplasma EIA detects the presence of 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: 709030, Lot Number: 709030M114, Device Identifier: 00840733101762.
- 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…
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 8 kits
- Distribution
- US Nationwide distribution in the states of OH, SC.
- Recall date
- March 31, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)