Recall Z-0134-2023 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
| Date | Oct 26, 2022 (initiated Sep 14, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Packaging process control |
| Action | On 09/14/22, recall notices were emailed to customers who were asked to do the following: 1. Cease all use, and isolate or quarantine affected devices pending disposal. 2. If affected devices are identified, contact the recalling firm at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results obtained using the affected SARS-CoV-2 Assay. If you suspect that you have encountered a false negative result with a patient sample, please contact the |
| Quantity | 5,141 (24 Cassettes) |
| Distribution | Distribution US nationwide, Indonesia, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.