FDA Medical Device Recalls (openFDA)
Lusys Laboratories, Inc.: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
- Recall number
- Z-0718-2022
- Recalling firm
- Lusys Laboratories, Inc.
- Product
- COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
- Status
- Open, Classified
- Initiated
- 2022-01-13
- Posted
- not on file
- Terminated
- not on file
- 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.
- Root cause
- 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
- 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
- Lot, serial or model codes
- Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QKO
- Firm FEI
- 3004473533
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28