COVID-19 diagnostic test kits recalled for specimen leakage risk
Meridian Bioscience is recalling 92 Revogene SARS-CoV-2 test kits due to potential specimen leakage from the cartridge, which could expose laboratory personnel to aerosolized COVID-19 virus.
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 FDA Class II recall involves potential exposure to SARS-CoV-2, a high-risk pathogen. Although no illnesses or exposures have been reported, the risk of occupational exposure to laboratory personnel from specimen leakage warrants a High severity designation per the rubric criteria for high-risk pathogens without reported illness.
Plain-English summary
Meridian Bioscience Inc is recalling 92 Revogene SARS-CoV-2_IVD real-time RT-PCR test kits (Catalog Number 410700) due to the potential for specimen leakage from the plastic microfluidic cartridge. This leakage poses a risk that laboratory personnel may be exposed to aerosolized specimens containing SARS-CoV-2.
The affected kits were distributed nationwide to laboratories in Arizona, California, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New York, Oregon, and Texas. The affected lot numbers are 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, and 410700P027.
Laboratory personnel should stop using test kits from the affected lots immediately. Contact Meridian Bioscience Inc for replacement kits or instructions on how to proceed. Facilities should verify the lot number of any Revogene SARS-CoV-2_IVD test kits in use to determine if they are affected by this recall.
The recalled product
- Product
- Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
- Manufacturer
- Meridian Bioscience Inc
- Affected units
- 92
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 (7)
- UDI: N/A Lot Numbers 410700P019
- 410700P020
- 410700P021
- 410700P022
- 410700P023
- 410700P024
- 410700P027
Distribution
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