Recall Z-0836-2022— Meridian Bioscience Inc
Class II · Ongoing
Class II FDA medical device recall by Meridian Bioscience Inc, initiated 2022-02-15. It names one FDA 510(k) clearance: K170558. 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. Reason: 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..
- Recalling firm
- Meridian Bioscience Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-15
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.