Revogene SARS-CoV-2_IVD real-time RT-PCR test intended recall
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Why was Revogene SARS-CoV-2_IVD real-time RT-PCR test intended recalled?
Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
- Product
- Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
- Recalling firm
- Meridian Bioscience Inc
- Quantity
- 92 kits
- Distribution
- US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
- Recall date
- February 1, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)