Meridian ImmunoCard Mycoplasma EIA Recalled for Potential False-Negative Results
Meridian Bioscience is recalling 8 ImmunoCard Mycoplasma EIA kits due to incorrect storage that could cause false-negative or invalid results, potentially delaying appropriate patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic device) where incorrect results could lead to delayed treatment and symptom progression, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Meridian Bioscience Inc is recalling 8 kits of the ImmunoCard Mycoplasma EIA, a medical device intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection by detecting IgM in serum. The recall is associated with Catalog Number 709030, Lot Number 709030M114, and Device Identifier 00840733101762.
The recall was initiated because the kits may have been stored incorrectly. Use of the kits after such storage could lead to a potential false-negative or invalid result. In the event of a false-negative, healthcare providers might incorrectly assume the cause of patient symptoms, potentially failing to administer appropriate treatment, which could allow symptoms to progress.
The affected kits were distributed nationwide in the United States, specifically in the states of Ohio and South Carolina. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
The recalled product
- 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.
- Manufacturer
- Meridian Bioscience Inc
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number: 709030
- Lot Number: 709030M114
- Device Identifier: 00840733101762.
Distribution
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