Revogene, Catalog no. 610210. IVD test instrument
Medical device recall Z-1479-2022. Published in FDA’s Enforcement Report on Aug 3, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 3, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 459 (394 US, 65 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Revogene, Catalog no. 610210. IVD test instrument
459 (394 US, 65 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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 231541 231573 231602 231255 231423 231430 231304 231311 231734 231231 231503 231457 231767 231750 231779 231780 231202 231234 231575 231822 231549 231472 231388 231567 231385 231543 231471 231802 231748 231638 231667 231518 231496 231732 231337 231714 231428 231295 231726 231708 231716 231598 231499 231340 231523 231588 231784 231786 231260 231513 231677 231803 231622 231623 231242 231493 231796 231489 231683 231799 231263 231266 231446 231470 231475 231637 231671 231746 231758 231801 231367 231286 231382 231268 231609 231378 231727 231433 231790 231578 231647 231590 231596 231335 231424 231153 231155 231240 231245 231246 231274 231281 231301 231323 231338 231339 231375 231393 231408 231467 231479 231483 231488 231682 231696 231710 231718 231720 231759 231771 231808 231814 231815 231816 231817 231818 231838 231839 231840 231841 231842 231843 231844 231845 231846 231847 231848 231849 231850 231851 231852 231853 231213 231330 231366 231373 231480 231563 231568 231444 231272 231418…
FDA’s list runs to 3,275 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 22, 2022.
- FDA classified it on Jul 28, 2022.
- FDA’s Enforcement Report published it on Aug 3, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Meridian Bioscience Inc, of Cincinnati, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,275 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.