MODERNA COVID-19 VACCINE (cx-024414) injection, suspension [Moderna US, Inc.]
Updated Date: Thu, 09 Sep 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 9, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Tue, 07 Sep 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 7, 2021 Category: Drugs & Pharmacology Source Type: alerts
Versea Diagnostics LLC - CareStart COVID19 Antigen Rapid Diagnostic Test - Class 2 Recall
CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Healgen COVID19 IgG/IgM Rapid Test Cassette - Class 2 Recall
Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity te...
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - Status COVID19/Flu Rapid Immunoassay - Class 2 Recall
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from nasopharyngeal swab specimens obtained from individuals, who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider, within the first five days of onset of symptoms. Emergency use of this test is limited to authorized laboratories. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
Versea Diagnostics LLC - FaStep COVID19 IgG/IgM Rapid Test Device - Class 2 Recall
FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. (CLIA Waived Laboratories) (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 4, 2021 Category: Medical Devices Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Fri, 03 Sep 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - September 3, 2021 Category: Drugs & Pharmacology Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Mon, 30 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 30, 2021 Category: Drugs & Pharmacology Source Type: alerts
MODERNA COVID-19 VACCINE (cx-024414) injection, suspension [Moderna US, Inc.]
Updated Date: Thu, 19 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 19, 2021 Category: Drugs & Pharmacology Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Wed, 18 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 18, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Tue, 17 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 17, 2021 Category: Drugs & Pharmacology Source Type: alerts
PFIZER-BIONTECH COVID-19 VACCINE (bnt162b2) injection, suspension [Pfizer Manufacturing Belgium NV]
Updated Date: Tue, 17 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 17, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Wed, 11 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 11, 2021 Category: Drugs & Pharmacology Source Type: alerts
Corowell covid-19 symptom screening test () [national bio green sciences limited liability company]
Updated Date: Mon, 02 Aug 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 2, 2021 Category: Drugs & Pharmacology Source Type: alerts
JANSSEN COVID-19 VACCINE (ad26.cov2.s) injection, suspension [Janssen Products, LP]
Updated Date: Mon, 19 Jul 2021 00:00:00 EDT (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 19, 2021 Category: Drugs & Pharmacology Source Type: alerts
