Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Num
Summary
The FDA issued a Class II for Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative dete by Meridian Bioscience Inc. Reason: Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized sp.
Details
Source
Device Recall
External ID
Z-1008-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
Lot/Code Info: UDI: N/A Lot Numbers 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Quantity Affected: 92 kits
Reason for Recall
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
Distribution
US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-15
Company
Cincinnati, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 114 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Meridian Bioscience Inc has 14 FDA actions in our database, including 9 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Meridian Bioscience Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meridian Bioscience Inc have FDA actions?
Meridian Bioscience Inc has 14 FDA actions in our database, including 9 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1008-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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