Revogene diagnostic device recalled for photomultiplier tube malfunction
Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.
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: Class II recall of a diagnostic device where photomultiplier tube malfunction may produce false-positive or indeterminate results. This represents a risk-of-harm product that could lead to patient mismanagement through diagnostic error, though no patient injuries have been reported.
Plain-English summary
Meridian Bioscience Inc is recalling Revogene diagnostic systems used for nucleic acid testing in clinical laboratories. The photomultiplier tube in affected units may have compromised functionality, resulting in false-positive or indeterminate test results.
The recall affects 452 units (398 in the United States, 54 outside the United States) distributed nationwide in the US and internationally in Australia, Chile, Italy, and Switzerland.
Clinical laboratories using affected devices should discontinue use immediately for patient testing and contact Meridian Bioscience for replacement or repair instructions. Laboratories should review test results from these devices to determine whether retesting is necessary.
The recalled product
- Product
- Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
- Manufacturer
- Meridian Bioscience Inc
- Hazard
- false-results
- device-malfunction
- diagnostic-error
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 (2)
- UDI: 00840733102318 All units in the field
- all serial numbers.
Distribution
Distributed nationwide across the United States.
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