Reported Aug 3, 2022 · Ongoing
Revogene, Catalog no. 610210. IVD test instrument
Meridian Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Meridian Bioscience Inc · 3471 River Hills Dr · Cincinnati, OH · 45244-3023
Is this the product you have?
- Revogene, Catalog no. 610210. IVD test instrument
- Lot codes and dates
- UDI-DI00840733102318 Firmware version V2.1.0
- Serial Numbers
459 of 459 codes
231529231645231175231224231293231297231707231807231737231292231300231466231736231703231713231589231427231450231509231511231760231797231555231327231426231273231731231764231383231530231532231610231614231619231693231705231819231820231821231507231643231151231400231188231248231284231391231221231492231618231787231776231654231660231595231625231172231686231687231691
- Amount recalled
- 459 (394 US, 65 OUS)
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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