Ascensia Diabetes Care US, Inc.: Contour¿ next GEN Blood Glucose Monitoring System

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.

Details from the source

Reason for recall: 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. Distribution: Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA. Quantity: 2,888 units Lot/code info: Model No.: 7917; Lot No. DM01T033P; Serial No. (UDI): 1057018 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057018), 1057019 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057019), 1057020 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057020), 1057023 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057023), 1057024 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057024), 1057025 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057025), 1057076 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057076), 1057077 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057077), 1057078 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057078), 1057079 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057079), 1057080 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057080), 1057081 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057081), 1057082 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057082), 1057083 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057083), 1057084 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057084), 1057085 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057085), 1057086 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057086), 1057087 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057087), 1057088 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057088), 1057089 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057089), 1057090 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057090

UPC codes

00301937917011

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.