Luminex Corporation Recall 90937
Description: ARIES SARS-CoV-2 Assay, REF: 50-10047
Luminex Corporation Recall 90937 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0134-2023 |
| Event ID | 90937 |
| Event Description | ARIES SARS-CoV-2 Assay, REF: 50-10047 |
| Product Type | Devices |
| Distribution | Distribution US nationwide, Indonesia, and Hong Kong. |
| Quantity | 5,141 (24 Cassettes) |
| Recall Reason | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. |
| Device Classification | 20221102 |
| Device Code Info | Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023 |
| Center Classification Date | 20221026 |
| Recall Initiation Date | 20220914 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | Letter |
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