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May 1, 2024

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on April 30, 2024. To view listings for other dates, see CDRH New - News and Updates.

• Class I Recall: BioMérieux Inc. Recalls VITEK 2 AST Kit due to Incorrect Ceftriaxone Concentrations 
• Collaborative Communities: Addressing Health Care Challenges Together (Updated)
• Federal Register: Laboratory Developed Tests
• Federal Register: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564