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U.S. Department of Health and Human Services

Class 2 Device Recall Revogene

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  Class 2 Device Recall Revogene see related information
Date Initiated by Firm February 15, 2022
Create Date March 30, 2022
Recall Status1 Open3, Classified
Recall Number Z-0836-2022
Recall Event ID 89666
510(K)Number K170558  
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product 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
Code Information UDI: 00840733102318 All units in the field, all serial numbers.
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information Contact Meridian Bioscience Technical Services (North America)
800-343-3858
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results. If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue.
Quantity in Commerce 452 units (398 US, 54 OUS)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = GenePOC Inc.
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