Contour¿ next GEN Blood Glucose Monitoring System
type: Dataset
description: FDA recall Z-2211-2023 — Ascensia Diabetes Care US, Inc. is recalling Contour¿ next GEN Blood Glucose Monitoring System (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Contour¿ next GEN Blood Glucose Monitoring System
  type: MedicalDevice
  manufacturer: Ascensia Diabetes Care US, Inc.
claims: FDA recall Z-2211-2023: Ascensia Diabetes Care US, Inc. is recalling Contour¿ next GEN Blood Glucose Monitoring System
claims: FDA classified recall Z-2211-2023 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2211-2023
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2211-2023
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Ascensia Diabetes Care US, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2023-05-19
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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), 1057091 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057091), 1057092 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057092), 1057093 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057093), 1057094 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057094), 1057095 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057095), 1057096 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057096), 1057097 ((01)00301937917011(17)270901(10)DM01T033P(21)7917-1057097), 1057098 ((01)0…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: Domestic: CA, CO, FL, IN, MO, NJ, NY, OH, RI, SC, TN, TX, & VA.
      status: recorded

FDA recall Z-2211-2023: Ascensia Diabetes Care US, Inc. is recalling Contour¿ next GEN Blood Glucose Monitoring System
type: Claim
text: The FDA logged enforcement record Z-2211-2023: Ascensia Diabetes Care US, Inc. is voluntarily recalling Contour¿ next GEN Blood Glucose Monitoring System — reason: 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-19. Affected lots/codes: 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(1…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-2211-2023 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.