Recall Z-0718-2022— Lusys Laboratories, Inc.
Class I · Ongoing
Class I FDA medical device recall by Lusys Laboratories, Inc., initiated 2022-01-13. FDA's recall record names no specific 510(k) clearance for this event. Product: COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111. 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..
- Recalling firm
- Lusys Laboratories, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-01-13
- Firm location
- San Diego, CA, United States
Product description
COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.