FDA MedWatch- Lyra SARS-CoV-2 Assay (M120) by Quidel

July 9, 2021

Lyra SARS-CoV-2 Assay (M120) by Quidel: Class I Recall - Due to Risk of False Negative Results

Company Announcement

Limar Hand Sanitizer Packaged in 4.0 oz Bottles by Ardil Comercial: Recall

July 2, 2021

Company Announcement

FDA In Brief: FDA Authorizes Longer Time for Refrigerator Storage of Thawed Pfizer-BioNTech COVID-19 Vaccine Prior to Dilution, Making Vaccine More Widely Available

May 24, 2021

The following quote is attributed to Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research:

CMS Contract for ESRD Network 11 and Introducing Superior Health Quality Alliance

April 26, 2021

CMS Contract for End Stage Renal Disease (ESRD) Network 11

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

April 19, 2021

Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

Cases of Cerebral Venous Sinus Thrombosis with Thrombocytopenia after Receipt of the Johnson & Johnson COVID-19 Vaccine

As of April 12, 2021, approximately 6.85 million doses of the Johnson & Johnson (J&J) COVID-19 vaccine (Janssen) have been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S.

FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

February 27, 2021

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

Date Issued: January 4, 2021

Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps

Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues

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