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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- 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
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