Luminex Corporation Recall 89303
Description: ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Luminex Corporation Recall 89303 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0498-2022 |
| Event ID | 89303 |
| Event Description | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan. |
| Quantity | 296 kits |
| Recall Reason | Impacted lot may leak inside the ARIES instrument. |
| Device Classification | 20220126 |
| Device Code Info | Lot number AB1703A |
| Center Classification Date | 20220114 |
| Recall Initiation Date | 20210416 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | |
| Similar To |