Meridian Bioscience recalls ImmunoCard Mycoplasma EIA kits that may give false-negative results if stored incorrectly, risking missed diagnosis of Mycoplasma pneumoniae infection.
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.
Meridian Bioscience is recalling ImmunoCard Mycoplasma EIA kits that could give false-negative results if stored incorrectly. This might lead to missing symptoms of Mycoplasma pneumoniae infection and delayed treatment.
Incorrect storage of the kits can cause false-negative results. This means the test might incorrectly show no infection when one exists, leading to missed symptoms and delayed treatment.
People using the ImmunoCard Mycoplasma EIA kits for Mycoplasma pneumoniae testing. Those who stored the kits incorrectly may have missed diagnosis of infections.
Check for catalog number 709030, lot number 709030M114, or device identifier 00840733101762 on the kit packaging. The kits are intended for diagnosing recent Mycoplasma pneumoniae infections.
Ensure the kits are stored correctly to avoid false-negative results.
No, the recall is for potential false-negative results, not physical injury.
The recall does not specify a remedy, so check storage conditions to avoid false negatives.
Look for catalog number 709030, lot number 709030M114, or device identifier 00840733101762 on the kit packaging.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-1299-2021 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-1299-2021 from Meridian Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
