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Meridian Bioscience Inc Recall: Revogene, For In Vitro Diagnostic use in performing nuclei

Meridian Bioscience Inc Recall: Revogene, For In Vitro Diagnostic use in performing nuclei is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Meridian Bioscience Inc; Product: Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian brand

Recalling firmMeridian Bioscience Inc
ProductRevogene, 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 recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionWorldwide 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.
Recall initiated20220215
Recall numberZ-0836-2022
Categorydevice
StateOH
CountryUnited States

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