medical Class II Updated 2022-04-06

Meridian Bioscience Inc recalls Revogene, For In Vitro Diagnostic use in performing nucleic

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00840733102318 All units in the field, all serial numbers.
View official government recall

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