Recall Z-0553-2022 ยท OOI Real Time Nucleic Acid Amplification System
Luminex Corporation
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
| Date | Nov 17, 2021 |
| Status | Terminated |
| Reason | Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/17/2021, the firm notified affected customers via letter titled, "URGENT: MEDICAL DEVICE RECALL ARIES HSV 1&2 Assay." The letter indicated, if you observe any leaks, please contact Luminex Global Support Services at support@luminexcorp.com. Please inform all those who need to be aware within your organization of this potential product performance issue. Please contact Luminex Global Support Services at support@luminexcorp.com at your earliest convenience if you have a Kit with an affected lot to arrange for its replacement, and to confirm the disposal of any remaining Kits in your inve |
| Quantity | 329 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of New Jersey, California, Connecticut, Minnesota, Missouri, New Jersey, New Mexico, Pennsylvania, Tennessee, Washington, and Wisconsin) and the country of Malaysia. |
| 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 |