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

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.