Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Reported: March 16, 2022 Initiated: January 13, 2022 #Z-0717-2022
Product Description
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)
Reason for Recall
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.
Details
- Recalling Firm
- Lusys Laboratories, Inc.
- Units Affected
- 90,849 kits
- 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
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test). Recalled by Lusys Laboratories, Inc.. Units affected: 90,849 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 16, 2022. Severity: Critical. Recall number: Z-0717-2022.
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