Meridian Bioscience Inc Recall 89666
Description: 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
Meridian Bioscience Inc Recall 89666 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0836-2022 |
| Event ID | 89666 |
| Event Description | 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 |
| Product Type | Devices |
| 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. |
| Quantity | 452 units (398 US, 54 OUS) |
| Recall 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. |
| Device Classification | 20220406 |
| Device Code Info | UDI: 00840733102318 All units in the field, all serial numbers. |
| Center Classification Date | 20220330 |
| Recall Initiation Date | 20220215 |
| Recalling Firm | Meridian Bioscience Inc |
| Initial Notification | Letter |
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