October 30, 2025

Oct

FDA Recall: Software defect could result in the missed detection of a hyperglycemic or hypoglycemic event

October 30, 2025Allison PateNews

Company: Dexcom, Inc. Date of Enforcement Report: 10/30/2025 Class: I PRODUCT: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous...

Oct

FDA Recall: Software error may lead to incorrect diagnosis or error in patient management.

October 30, 2025Allison PateNews

Company: Beckman Coulter, Inc. Date of Enforcement Report: 10/30/2025 Class: II PRODUCT: CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E. Recall Number: Z-0412-2026 REASON: Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device...

FDA Recall: Software defect could result in the missed detection of a hyperglycemic or hypoglycemic event

FDA Recall: Software error may lead to incorrect diagnosis or error in patient management.

Upcoming Public Courses

Corporate Office

Day

FDA Recall: Software defect could result in the missed detection of a hyperglycemic or hypoglycemic event

FDA Recall: Software error may lead to incorrect diagnosis or error in patient management.

Upcoming Public Courses

Corporate Office