This Field Safety Notice is issued by Roche Diabetes Care regarding a manufacturing issue with the Accu-Chek Spirit 3.15 ml cartridge system, which can potentially lead to insulin leakage.
The issue was identified through quality monitoring and market surveillance processes, and it affects cartridges manufactured between March 01, 2024, and October 31, 2024.
Actions to be taken:
Users and healthcare providers are advised to discontinue using affected cartridges and retain them until further instructions are received. Alternative therapy methods should be consulted until replacement cartridges are available.
Roche Diabetes Care has paused shipment of potentially impacted material and is implementing corrective measures to eliminate the potential cause of leakage.
Replacement cartridges are expected to be available by the end of January 2025.
Manual:
Download: User Manual for Roche Accu-Chek Spirit 3.15 ml Cartridge System
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