MODERNA COVID-19 VACCINE (cx-024414) injection, suspension [Moderna US, Inc.]
Updated Date: Wed, 07 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 7, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Mon, 05 Apr 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - April 5, 2021 Category: Drugs & Pharmacology Source Type: alerts
MODERNA COVID-19 VACCINE (cx-024414) injection, suspension [Moderna US, Inc.]
Updated Date: Wed, 31 Mar 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 31, 2021 Category: Drugs & Pharmacology Source Type: alerts
LumiraDx - LumiraDx Instrument - Class 2 Recall
Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. (Source: Medical Device Recalls)
Source: Medical Device Recalls - March 27, 2021 Category: Medical Devices Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Mon, 22 Mar 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 22, 2021 Category: Drugs & Pharmacology Source Type: alerts
Health Fraud & COVID-19: What You Need to Know
RADM Richardae Araojo is joined by CAPT Jason Humbert and Minerva Rogers from the Health Fraud Branch in the Office of Regulatory Affairs at FDA to discuss FDA's efforts to stop fraudulent products from reaching our markets, especially those claiming to prevent, treat, or cure COVID-19. (Source: FDA Health Fraud Alerts)
Source: FDA Health Fraud Alerts - March 5, 2021 Category: Medical Law Authors: FDA Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Fri, 05 Mar 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 5, 2021 Category: Drugs & Pharmacology Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Mon, 01 Mar 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - March 1, 2021 Category: Drugs & Pharmacology Source Type: alerts
Confirm Biosciences Inc - Orient Gene COVID 19 IgG/ IgM Rapid Test Cassette - Class 2 Recall
Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2021 Category: Medical Devices Source Type: alerts
Confirm Biosciences Inc - Healgen COVID19 IgG/IgM Rapid Test Cassette - Class 2 Recall
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 17, 2021 Category: Medical Devices Source Type: alerts
Becton Dickinson & Co. - BioGX SARSCoV2 Reagents for BD MAX System - Class 2 Recall
BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 6, 2021 Category: Medical Devices Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Wed, 03 Feb 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - February 3, 2021 Category: Drugs & Pharmacology Source Type: alerts
Biomeme, Inc. - Biomeme SARSCoV2 test - Class 3 Recall
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller version 6.4.3. The cycler has a "baseboard" unit with firmware and associated software component that control motorized movements of the optical filter carriage used for PCR detection. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 2, 2021 Category: Medical Devices Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Thu, 28 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 28, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) suspension [Janssen Products, LP]
Updated Date: Wed, 27 Jan 2021 00:00:00 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - January 27, 2021 Category: Drugs & Pharmacology Source Type: alerts
