FDA Classifies Mesa Biotech Recall of Accula SARS-CoV-2 Tests as Class I
On April 6, Mesa recalled certain test kit lots because they had an increased risk of yielding false positive results due to contamination at the manufacturing facility.
IVD company executives noted that the acceptance and acceleration of decentralized care models have increased, enabling more effective testing for many conditions.
In Brief This Week: Qiagen, Oncocyte, Myriad Genetics, Mesa Biotech, and More
News items for the in vitro diagnostics industry for the week of May 31, 2021.
Miniaturized sample-to-answer devices in development hint at an evolving molecular diagnostics landscape but launch timelines for these platforms remain unclear.
FDA Posts Info on Impact of SARS-CoV-2 Mutations on Test Effectiveness
The FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations.