Lusys Laboratories, Inc. Recall 89539
Description: Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Lusys Laboratories, Inc. Recall 89539 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0717-2022 |
| Event ID | 89539 |
| Event Description | Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test) |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing |
| Quantity | 90,849 kits |
| Recall Reason | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. |
| Device Classification | 20220316 |
| Device Code Info | Part Number: I-114(N) Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA) |
| Center Classification Date | 20220310 |
| Recall Initiation Date | 20220113 |
| Recalling Firm | Lusys Laboratories, Inc. |
| Initial Notification | Letter |
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