FDA (Devices) recall action 84891
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Dexcom Inc is recalling G4 PLATINUM systems because hydroxyurea use may cause falsely elevated glucose readings.
Dexcom Inc is recalling G6 Continuous Glucose Monitoring Systems because the anti-neoplastic drug hydroxyurea may cause falsely elevated glucose readings.
Dexcom Inc is recalling G5 and G4 PLATINUM Continuous Glucose Monitoring Systems because hydroxyurea use may cause falsely elevated glucose readings.