Drug RecallsPotential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue: FDA Safety Communication Posted on by Editor Date: 11/10/2021 Product type: Medical Device US-FDA Link: https://www.fda.gov/medical-devices/safety-communications/potential-false-positive-results-certain-lots-ellume-covid-19-home-tests-due-manufacturing-issue-fda MedWatch: The FDA Safety Information and Adverse Event Reporting Program Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect