Luminex Corporation Recall 89244
Description: ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Luminex Corporation Recall 89244 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0553-2022 |
| Event ID | 89244 |
| Event Description | ARIES HSV 1&2 Assay, Catalog/REF# 50-10017 |
| Product Type | Devices |
| 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. |
| Quantity | 329 |
| Recall 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. |
| Device Classification | 20220209 |
| Device Code Info | Lot Numbers AB3600A and AB3560A |
| Center Classification Date | 20220202 |
| Recall Initiation Date | 20211117 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | |
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