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Dexcom CGM Alarm Issue Tagged As Class I Recall

FDA has labeled a DexCom alert about alarm activation failures with its G4 Platinum and G5 Mobile continuous glucose monitoring systems as a class I recall.

DexCom Inc.'s February alert about alarm problems with its G4 Platinum and G5 Mobile continuous glucose monitors for diabetics has been tagged as a class I recall, FDA said

April 11. The recall involves all models and all lots of the CGMs – a total of 263,540 units worldwide.

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