FDAMay 19, 2023device

Contour¿ next GEN Blood Glucose Monitoring System

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.

What to do

FDA enforcement status: Ongoing

Brands named

ascensia diabetes careascensiaascensia diabetes

UPCs

003019379170117917105701879171057019791710570207917105702379171057024791710570257917105707679171057077791710570787917105707979171057080

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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