Meridian Revogene RNA Software Upgrade Kits Recalled Due to False Negatives
Meridian Bioscience is recalling 124 Revogene RNA Software Upgrade Kits because the FDA withdrew the Emergency Use Application after false negative results were reported.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves the withdrawal of an Emergency Use Application due to reported false negative results, which poses a significant risk of misdiagnosis and potential harm to patients.
Plain-English summary
Meridian Bioscience Inc is recalling 124 Revogene RNA Software Upgrade Kits (Catalog Number: 610240). These kits are in vitro diagnostic (IVD) products used to install Revogene System Software version 4.2.0, import the Instrument Control Protocol file for RNA-based assays, and install the Assay Definition File (ADF). The recall covers all lot numbers and the products were distributed nationwide.
The recall was initiated because the FDA withdrew the Emergency Use Application (EUA) for the product after false negative results were reported. This withdrawal indicates that the software upgrade may not function as intended for RNA-based assays, potentially leading to inaccurate diagnostic outcomes.
Healthcare facilities and laboratories that possess these kits should stop using them immediately. Users should contact Meridian Bioscience Inc for instructions on how to return the affected units or obtain a replacement, as directed by the recalling firm.
The recalled product
- Product
- Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF)…
- Manufacturer
- Meridian Bioscience Inc
- Affected units
- 124
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 (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Meridian Bioscience Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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