Stop Using LuSys Laboratories COVID-19 Tests

COLA Inc. is engaged with the CDC’s Laboratory Outreach Communication System (LOCS) in the Division of Laboratory Systems (DLS) to transmit their public health messages to our laboratories and affiliates. There is an important announcement to share at this time. You can find more details by clicking on the links below:

On January 13, 2022, the CDC alerted laboratories that the Food and Drug Administration (FDA) has issued a safety communication warning test users, caregivers and healthcare professionals to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared or approved by the FDA for distribution or use in the United States. Also, the tests may be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx.