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
Reported: April 6, 2022 Initiated: February 15, 2022 #Z-0836-2022
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
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.
Details
- Recalling Firm
- Meridian Bioscience Inc
- Units Affected
- 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.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Meridian Bioscience Inc. Units affected: 452 units (398 US, 54 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0836-2022.
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