Recall Z-1524-2022 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Luminex Corporation
ARIES SARS-CoV-2 Assay
| Date | Jul 14, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 7/14/22 recall notices were emailed to consignees who were asked to review any results from the affected lot to confirm the validity of the results. In addition, all remaining cassettes from this lot should be discarded. Customers with questions are encouraged to contact the firm at: 1-877-785-2323 (U.S. and Canada), +1-512-381-4397 (Outside U.S. and Canada), support@luminexcorp.com |
| Quantity | 257 |
| Distribution | U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.