Revogene diagnostic test instrument recalled for burn risk from cooling failure
Meridian Bioscience recalled 459 Revogene diagnostic instruments due to a cooling protection failure that may expose users to heated components, risking minor burn injuries.
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: This defect is classified as High because it presents a risk-of-harm scenario where injury has not yet been reported. Although the cooling system malfunction could cause minor burns, the source explicitly states no hospitalizations or actual injuries have occurred, meeting the rubric criterion for Score 3.
Plain-English summary
Meridian Bioscience Inc is recalling the Revogene diagnostic test instrument (catalog no. 610210), an in vitro diagnostic device. A total of 459 units have been recalled, distributed in the US and to Australia, Chile, Italy, Qatar, and Switzerland.
The recall stems from a safety defect: when a test run is aborted, the device's cooling period protection does not activate. This allows operators to open the instrument lid before the cooling cycle is complete, exposing them to heated instrument components.
Incidental contact with the heated components may cause minor burn injuries. The affected devices have firmware version V2.1.0 and are identified by specific serial numbers listed in the recall notice. Affected facilities should verify their device's firmware version and serial number against the recall documentation.
The recalled product
- Product
- Revogene, Catalog no. 610210. IVD test instrument
- Manufacturer
- Meridian Bioscience Inc
- Hazard
Distribution
Distributed nationwide across the United States.
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