Coronavirus Antigen Detection Test System.

Brand Name: MiniDock

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Brand Name: Pluslife SARS-CoV-2 Card

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)

The liquid buffer component in the affected test kit lots was determined to have bacterial contamination. User may notice a slight odor when the buffer is brought close to the nose.

Products are labeled as:

Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.

Detect Covid-19 Test

There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit

Assigned vial lot numbers for the incorrect type of product. SARS-CoV-2 & Flu A/B lot numbers were incorrectly assigned to the positive and negative vial lot numbers for SARS-CoV-2 Ag LQCs within batch 2002204017, which should have been assigned SARS-CoV-2 Ag lot numbers resulting in an error message and preventing use of the LQC

Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002

COVID test kit shelf life was periodically extended, as real-time stability test timepoints passed, without FDA concurrence.

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CLIA ID.

Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02

Kits were labeled with incorrect expiration dates.