Tandem Diabetes Care recalls

Recall found. Tandem Diabetes Care is named in FDA Class II recall Z-3330-2026 covering Brand Name. Hazard: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia. Identifying details: Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only). Status: Ongoing.