Medtronic MiniMed, Inc.: Guardian 4 Glucose Sensor, , MMT-7040C1, MMT-7040C2,
Recall reason: Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 ¿m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.. Recalled by Medtronic MiniMed, Inc.. Distribution: Worldwide - US Nationwide distribution
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