FDA warns against using certain COVID-19 tests - MassDevice

FDA-logo-newThe FDA issued a statement recommending that clinical laboratories and healthcare providers stop using COVID-19 antibody tests on its “removed” list.

Found under the FDA’s FAQs on Testing for SARS-CoV-2 page, the removed list includes tests for which significant clinical performance problems were identified and cannot or have not been addressed by the manufacturer in a timely manner. Also included are tests for which an emergency use ization (EUA) request was not submitted within a reasonable period of time and tests voluntarily withdrawn by the manufacturers.

Although tests on the “removed” list shouldn’t be distributed, laboratories and providers may still have the tests within their stock and may have used the tests in the past, according to the FDA statement.

The FDA recommends that laboratories and healthcare providers cease use of the tests on the “removed” list and evaluate whether prior test results generated using such tests may have been incorrect and if the patient should be retested using an FDA-ized test.

Additionally, the agency said providers should remove such tests from their stock and report any issues with COVID-19 tests to the FDA.

False-positive serology tests can lead to an incorrect assessment regarding a person’s immune response to SARS-CoV-2, and could lead to someone not taking the necessary precautions against virus exposure under the impression of having immunity. False-negatives can lead to a person restricting activities deemed acceptable for individuals with evidence of an antibody response to SARS-CoV-2, and may lead to further unnecessary diagnostic evaluations.

RSS From Medical Design & Outsourcing

  • CVRx CEO details the path from being engineer to medtech executive
    Nadim Yared, CEO of CVRx[/caption] This week, CVRX reported positive six-month trial results for its Barostim Neo, an FDA-approved treatment for heart failure. The results follow years of close work between the agency and CVRx, one of the more ambitious startups in medtech. CVRx is targeting a huge clinical need with novel neuromodulation technology. In… […]
  • What’s next for nitinol tubing?
    Nitinol’s unique properties have made it the darling of the medical device industry. A novel technique for mechanically joining nitinol to other metal tubing could reduce cost and mitigate risk. Mark Broadley, Viant Nitinol has revolutionized the medical device industry. With its flexible superelasticity, shape memory and biocompatibility, nitinol has become a go-to material for… […]
  • Report: Haemonetics’ blood-collection devices could leave particles in donors
    A consortium of news outlets is questioning the safety of Haemonetics (NYSE:HAE) blood-collection devices, claiming that particles have been detected in donors whose plasma was extracted by the machines. According to a report in the Miami Herald, whistleblower documents indicate that more than 150 Haemonetics customer reports have been made regarding the presence of particles by plasma collection centers and heathcare… […]
  • Spinal Elements’ cervical fixation system wins FDA nod
    Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its Sapphire X product for anterior cervical fixation. Sapphire X is comprised of integrated instrumentation and high-angulation screws designed to help surgeons perform a procedure while preserving the patient’s skeletal and muscle tissue. The instrumentation is designed to reduce procedural steps… […]
  • How COVID-19 impacts FDA interactions with medical device manufacturers
    By Stewart Eisenhart, Emergo Group The US Food and Drug Administration may revise performance goals and timelines set under the Medical Device User Fee Amendments IV (MDUFA IV) as emergency efforts targeting the coronavirus pandemic take up more of the agency’s time. Get the full story here at the Emergo Group’s blog. The opinions expressed… […]
  • Switchback Medical adds ‘sandbox approach’ to device testing
    Contract manufacturer Switchback Medical (Maple Grove, Minn.) today announced that it has added a new division. Switchback BioSim Innovations offers functional dynamic biosimulator model development, cell culture services and physician training, according to the company. Biosimulator models use animal and human tissue to create functional models, such as a pumping heart with working valves to… […]
  • Smith College team wins ventilator design challenge
    A team of Smith College engineering alumnae, staff and faculty has won the CoVent-19 Challenge to design a rapidly deployable ventilator to address shortages caused by the COVID-19 pandemic, particularly in developing countries. A dozen anesthesiology resident physicians from Massachusetts General Hospital kicked off the public challenge April 1, attracting 200 entries. The 30-person team… […]
  • FDA gives certain device makers more time to add UDIs
    The FDA said today that it will grant manufacturers of Class 1 and unclassified medical devices and certain others more time to add unique device identifiers (UDIs) to their products. These companies will now have until Sept. 24, 2022 to comply with the agency’s UDI rule, including standard date formatting, labeling and Global Unique Device… […]
  • Eurofins launches 10-minute COVID-19 exposure testing device
    Eurofins (Paris:ERF.PA) announced today that it launched its rapid point-of-care testing devices to identify past exposure to COVID-19. The serology-based, finger-prick tests detect antibodies with a sensitivity of 94.5% from 19 days following the onset of symptoms, with results coming in just 10 minutes, according to a news release. Get the full story at our sister site,… […]
  • How is RF technology shaping the future of medtech?
    RF technology, including microwaves, isn’t just about wireless communications or military radar these days. Times Microwave Systems experts point out that it is increasingly important when it comes to medtech. Many medical electronics systems such as magnetic resonance imaging (MRI) systems for cancer detection rely on RF/microwave technology. Times Microwave Systems (Wallingford, Conn.) is hosting… […]
  • Medical device litigation and COVID-19: What you need to know
    The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights. Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits. “I say,… […]