COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
- Company
- Lusys Laboratories, Inc.
- Recall Initiated
- January 13, 2022
- Recall Number
- Z-0718-2022
- Quantity
- 33,955 kits
- Firm Location
- San Diego, CA
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.
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
Lot / Code Info
Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Root Cause
No Marketing Application
Action Taken
On 01/13 and 24/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via certified US Mail to customer informing them that the COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests are being recalled because these tests have not received FDA Emergency Use Authorization, nor have these test been cleared or approved by FDA for commercial distribution. Therefore, these tests cannot be legally marketed or distributed in the U.S., nor can they be legally exported from the U.S.. Because the abovementioned products were not authorized, cleared, or approved by FDA, the performance characteristics of these tests have not been adequately established, might presenting a high risk of false positive and false negative results. Customers are instructed to: 1. Immediately discontinue to use these tests. 2. If your firm has distributed these products, immediately provide all consignees with a copy of this recall notification. 3. Discard or destroy all COVID-19 tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC, or return the tests to the following address: 7220 Trade Street, Suite 338, San Diego, CA, 92121, before January 30, 2022. For further questions regarding this Recall: -Call Telephone Number - 858-733-2128, or -email onestep@lusyslab.com