Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Re
Summary
The FDA issued a Class II for Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clin by Meridian Bioscience Inc. Reason: The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-posi.
Details
Source
Device Recall
External ID
Z-0836-2022
Action Date
2022-04-06
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: UDI: 00840733102318 All units in the field, all serial numbers.
Quantity Affected: 452 units (398 US, 54 OUS)
Reason for Recall
The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-15
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 123 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-0836-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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