Abbott Defends Its Rapid COVID-19 Test

FDA alerted the public on Thursday that early data from independent studies suggests potential inaccurate results from using the Abbott ID NOW point-of-care diagnostic for COVID-19. The agency has also received 15 adverse event reports about the ID NOW test that suggests some users are receiving inaccurate negative results. Abbott went on the defensive and pointed out that test outcomes depend on a number of factors, including conformity to the way the test was designed to be run. Some researchers, for example, reported transporting the samples to a central lab and running the test an hour or two after collection. That's a problem because the test is meant to be used near the patient, with the swab going directly from the patient's nose to the machine.

Breast Implant Makers Land in Hot Water

FDA cited Allergan for neglecting post-approval study obligations for two models of breast implants, even though both models were pulled from the market last year. FDA also cited Ideal Implant of failing to comply with good manufacturing parctices and adverse event reporting requirements. The warning letter to Implant is based on an FDA inspection earlier this year.

Procedure Recovery May Be Slower than Expected