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U.S. Department of Health and Human Services

Class 1 Device Recall LuSys Laboratories

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  Class 1 Device Recall LuSys Laboratories see related information
Date Initiated by Firm January 13, 2022
Create Date March 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-0718-2022
Recall Event ID 89539
Product Classification Reagent, coronavirus serological - Product Code QKO
Product COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
Code Information Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
Recalling Firm/
Manufacturer		 Lusys Laboratories, Inc.
7220 Trade St Ste 338
San Diego CA 92121-2324
For Additional Information Contact james Lu
858-733-2128
Manufacturer 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.
FDA Determined
Cause 2		 No Marketing Application
Action 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
Quantity in Commerce 33,955 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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