Luminex Corporation Recall 90698
Description: ARIES SARS-CoV-2 Assay
Luminex Corporation Recall 90698 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1524-2022 |
| Event ID | 90698 |
| Event Description | ARIES SARS-CoV-2 Assay |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA. |
| Quantity | 257 |
| Recall Reason | SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated. |
| Device Classification | 20220824 |
| Device Code Info | Lot: AB4042A |
| Center Classification Date | 20220817 |
| Recall Initiation Date | 20220714 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | Letter |
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