Recall Z-1479-2022 ยท OOI Real Time Nucleic Acid Amplification System
Meridian Bioscience Inc
Revogene, Catalog no. 610210. IVD test instrument
| Date | Jun 22, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | 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 tea |
| Quantity | 459 (394 US, 65 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170558 | revogene Genepoc, Inc., May 25, 2017 |