The Recall Desk
HighFDA (Devices)·Z-2211-2023·Announced 2023-07-26

Blood Glucose Meters Display Glucose Levels in Wrong Unit of Measure

Ascensia is recalling blood glucose meters that display measurements in mmol/L instead of mg/dL. If not caught, the incorrect unit may cause patients to misread their glucose levels with serious health consequences.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical but significant: incorrect unit-of-measure display could cause patients to dangerously misread blood glucose levels, potentially leading to medical intervention. Per rubric, risk-of-harm products without reported injury score at maximum 3 (High).

Plain-English summary

Ascensia Diabetes Care US, Inc. is recalling blood glucose meters from the Contour® next GEN system, Model 7917, Lot Number DM01T033P. A total of 2,888 meters are affected, with 579 distributed in the United States across California, Colorado, Florida, Indiana, Missouri, New Jersey, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, and Virginia.

The affected meters are factory-configured to display blood glucose measurements in mmol/L (the metric unit) instead of mg/dL (the standard U.S. unit). If a patient does not notice this unit discrepancy, the glucose reading may be misinterpreted as lower than the actual blood glucose level.

Misreading blood glucose levels in this manner could result in a patient's blood glucose level remaining elevated without appropriate treatment. This may potentially lead to an injury requiring immediate medical intervention. The FDA has classified this recall as Class II.

The recalled product

Product
Contour¿ next GEN Blood Glucose Monitoring System
Manufacturer
Ascensia Diabetes Care US, Inc.
Category
Medical Device — Blood Glucose Meter
Hazard
Affected units
2,888

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model No.: 7917
  • Lot No. DM01T033P
  • 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)

Distribution

Distributed in 13 states:

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