FDA Device recall Z-0836-2022
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories
- FDA Device
- Class II
- ongoing
- Published 2022-04-06
On 2022-04-06 the FDA classified a Class II recall of Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories by Meridian Bioscience, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0836-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-15 |
| Published | 2022-04-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
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.
Identifiers
| code_info | UDI: 00840733102318 All units in the field, all serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Meridian Bioscience recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0836-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.