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FDA: COVID-19 Antigen, Antibody Tests By LuSys Labs Could Give Wrong Results, Shouldn’t Be Used

Tests might’ve been sold under names Luscient Diagnostics, Vivera Pharmaceuticals or EagleDx

Executive Summary

The US FDA on 11 January issued a safety alert that the diagnostics made by LuSys Laboratories could give false-positive or false-negative results. The agency has asked health care providers and others to stop using the tests.

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Stop Using E25Bio COVID-19 Antigen Tests, FDA Says

The US FDA is asking health care providers and the public to cease using the E25Bio COVID-19 Direct Antigen Rapid Test because the agency is concerned about the diagnostic giving false results. The FDA is also worried that people could injure themselves when self-collecting a sample from the nose or throat.

FDA Warns: Don’t Use CovClear, ImmunoPass COVID-19 Tests; High-Risk Class I Recall Underway

The US FDA said on 28 January that it’s worried about the potential for false-negative or false-positive results given from the diagnostics, which were made by Empowered Diagnostics. The company has recalled the tests because they weren’t authorized by the agency for use in the US.

Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot

In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?


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