Tandem Diabetes Care, Inc.: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 So
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Tandem Diabetes Care, Inc.
- Product
- Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-07-16
- Code info
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Product quantity
- 177
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Diego
- State
- CA
- Country
- United States
- Event id
- 99589
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