Recall Z-0836-2022 ยท OOI Real Time Nucleic Acid Amplification System
Meridian Bioscience Inc
Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
| Date | Feb 15, 2022 |
| Status | Open, Classified |
| Reason | The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results. |
| Root cause | Component design/selection |
| Action | A Letter dated 02/15/2022 sent via FedEx notified users of the risk of false-positives and provided instructions on how to recognize a compromised photomultiplier tube via error codes and based on various combinations of positive and indeterminate results. If a positive result with the negative control is obtained or false positive suspected, users are to contact Technical Service and cease using the instrument. The company is developing software solution aimed at identifying photomultiplier tubes that are at risk for failure and is seeking a hardware fix to this issue. |
| Quantity | 452 units (398 US, 54 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OR, PA, PR, RI, SD, TN, TX, UT, VA, VT, WI, WV and the countries of Australia, Chile, Italy, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170558 | revogene Genepoc, Inc., May 25, 2017 |