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U.S. Department of Health and Human Services

Class 2 Device Recall Revogene

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  Class 2 Device Recall Revogene see related information
Date Initiated by Firm June 22, 2022
Create Date July 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1479-2022
Recall Event ID 90549
510(K)Number K170558  
Product Classification real time Nucleic acid amplification system - Product Code OOI
Product Revogene, Catalog no. 610210. IVD test instrument
Code Information 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 231434 231319 231305 231324 231279 231631 231477 231252 231632 231612 231309 231265 231288 231165 231490 231247 231290 231355 231495 231603 231571 231587 231591 231282 231179 231262 231751 231789 231694 231306 231318 231307 231599 231405 231422 231551 231702 231804 231464 231624 231663 231468 231469 231756 231303 231352 231485 231659 231800 231504 231510 231462 231463 231723 231259 231314 231717 231823 231806 231425 231384 231761 231343 231753 231791 231285 231497 231650 231605 231657 231704 231277 231180 231410 231412 231414 231386 231478 231166 231775 231241 231275 231283 231287 231634 231795 231525 231547 231465 231244 231289 231344 231553 231562 231651 231724 231754 231342 231436 231445 231456 231473 231611 231615 231437 231438 231451 231600 231455 231491 231394 231454 231636 231597 231627 231407 231448 231512 231524 231576 231365 231353 231440 231441 231442 231592 231701 231325 231439 231329 231403 231772 231621 231298 231317 231579 231788 231635 231742 231516 231577 231629 231413 231536 231539 231585 231725 231763 231280 231253 231565 231689 231310 231581 231785 231162 231498 231358 231453 231356 231417 231572 231302 231646 231745 231227 231798 231401 231254 231505 231616 231755 231781 231291 231229 231336 231626 231167 231232 231236 231237 231238 231239
Recalling Firm/
Manufacturer		 Meridian Bioscience Inc
3471 River Hills Dr
Cincinnati OH 45244-3023
For Additional Information Contact Ryan Spradling
800-343-3858
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Device Design
Action On June 22, 2022, the firm notified customers via email. Customers were instructed that if a run is aborted and an error code presented, they SHOULD NOT open the instrument. DO NOT touch the retention ring or the inside of the lid as they may be hot. The firm recommends that customers wait approximately 10 minutes to allow the instrument to cool prior to opening the lid and removing the test devices. The firm has developed a firmware solution to prevent the lid from being opened after an aborted run prior to the completion of the cooling period. The Meridian Bioscience Technical Services team will contact you to set up an appointment for firmware installation once available.
Quantity in Commerce 459 (394 US, 65 OUS)
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OOI and Original Applicant = GenePOC Inc.
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