February 14, 2023
FDA: Class I recall of Skippack Medical Lab COVID-19 tests
Editor's Note
The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious.
The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA.
Distribution dates were January 2022.
Free Daily News
- Robotic surgery transforms ORs as market expands
- Study: Wildfire smoke raises hospital borrowing, patient care costs
- Study: Hospital bed shortage looms as aging population drives demand
- FDA designates Class 1 recall for pacemakers
- Chinese medical devices threaten US healthcare cybersecurity
- Preoperative SGLT2i use does not raise DKA risk in emergency surgery
- AI boosts accuracy in surgical reports, outperforming surgeons
- AI models improve prediction of surgical complications using preoperative clinical notes
- Ambient AI healthcare documentation gains traction as capabilities expand
- Healthcare M&A faces tighter review as FTC retains guidelines
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement