Detect Recalls Thousands Of COVID-19 Tests Due To Risk Of False Negative Results
Executive Summary
Detect, Inc. is recalling several lots of diagnostic products that test for COVID-19. The Guilford, CT-based company says the tests may report inaccurate results.
You may also be interested in...
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
FDA Takes Another Swing At Banning Electrical Shock Devices
The US FDA wants to ban devices that use an electrical shock to stop aggressive behavior. The agency attempted to ban the devices in 2020 but failed after it was challenged in court.
Congress Revives Talks On LDTs With Clock Ticking On FDA Rule
During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.