Recall Z-0498-2022 ยท OOI Real Time Nucleic Acid Amplification System
Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
| Date | Apr 16, 2021 |
| Status | Terminated |
| Reason | Impacted lot may leak inside the ARIES instrument. |
| Root cause | Equipment maintenance |
| Action | On 04/16/2021, the firm notified affected customers via email using a letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated the following: " Please inform all those who need to be aware within your organization of this potential product performance issue. At this time, you should destroy any inventory of these ARIES HSV 1&2 Assays. Please follow the "Steps in Voluntary Recall" directions found on the following pages of this notification. The Acknowledgment and Receipt Form must be completed and returned, even if you do not have any remaining product, by April |
| Quantity | 296 kits |
| 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, Wisco |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161495 | ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) Luminex Corporation, Jun 30, 2016 |