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.
What this means for you
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
Related recalls
Same manufacturer · Meridian Bioscience Inc
See all →- HighC. difficile assay recalled over declining performance and false negative results
FDA (Devices) · 2026-01-14
- HighGroup B strep test kits recalled over buffer caps missing gaskets
FDA (Devices) · 2025-11-26
- HighC difficile test kits recalled over buffer caps missing a gasket
FDA (Devices) · 2025-11-26
- HighCardinal Health Stool Transportation System Recalled for Vial Leakage
FDA (Devices) · 2023-12-20
- HighMedical Device Recall: Para-Pak Zn-PVA Stool Collection Vials for Leakage Risk
FDA (Devices) · 2023-12-20
Same hazard · false negative result
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
- HighMedical device test system recalled for decreased reactivity and false-negative results
FDA (Devices) · 2022-12-07