Abbott
FDA Classifies Abbott SARS-CoV-2 Molecular Test Recall as Class I Due to False Positives
Last month, the agency alerted users to the potential of false positives due to overflow of the PCR reaction mixture into neighboring wells of the assay reagent tray.
US DoD Awards Celltrion, Abbott Contracts for SARS-CoV-2 POC Rapid Antigen Tests
Celltrion will supply its DiaTrust tests to support military bases, long-term care facilities, community testing sites, and other designated places weekly.
IVD company executives noted that the acceptance and acceleration of decentralized care models have increased, enabling more effective testing for many conditions.
US Department of Defense Awards $647M to Procure Rapid Antigen Tests
The US Department of Defense will procure rapid antigen tests from OraSure Technologies, Quidel, Abbott, and Intrivo.
FDA Warns of Potential False Positives With Abbott SARS-CoV-2 Molecular Tests
The agency said the issue could be related to current mixing parameters of the PCR reaction mixture resulting in overflow in wells of the reagent tray.