FDA Device recall Z-1479-2022
Revogene, Catalog no. 610210
- FDA Device
- Class II
- ongoing
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Revogene, Catalog no. 610210 by Meridian Bioscience, citing when a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1479-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-22 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meridian Bioscience |
| Distribution | US |
Product
Revogene, Catalog no. 610210. IVD test instrument
Reason
When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
Identifiers
| code_info | UDI-DI: 00840733102318 Firmware version V2.1.0 Serial Numbers: 231529 231645 231175 231224 231293 231297 231707 231807…UDI-DI: 00840733102318 Firmware version V2.1.0 Serial Numbers: 231529 231645 231175 231224 231293 231297 231707 231807 231737 231292 231300 231466 231736 231703 231713 231589 231427 231450 231509 231511 231760 231797 231555 231327 231426 231273 231731 231764 231383 231530 231532 231610 231614 231619 231693 231705 231819 231820 231821 231507 231643 231151 231400 231188 231248 231284 231391 231221 231492 231618 231787 231776 231654 231660 231595 231625 231172 231686 231687 231691 231692 231749 231160 231653 231673 231220 231533 231697 231617 231765 231261 231661 231664 231738 231783 231170 231374 231381 231688 231320 231774 231582 231583 231389 231402 231698 231271 231564 231494 231601 231258 231662 231566 231228 231296 231521 231526 231527 231649 231656 231205 231712 231312 231395 231399 231398 231675 231299 231655 231486 231557 231762 231546 231482 231223 231460 231586 231684 231642 231706 231560 231730 231487 231538 231542 231545 231548 231554 231559 231561 231648 231380 231528 231537 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1479-2022%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.