FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
type: Dataset
description: FDA recall Z-2692-2024 — Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System (Devices, Class I). 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: FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
  type: MedicalDevice
  manufacturer: Abbott Diabetes Care, Inc.
claims: FDA recall Z-2692-2024: Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
claims: FDA classified recall Z-2692-2024 as Class I
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-2692-2024
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-2692-2024
      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 I
      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: Abbott Diabetes Care, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-07-24
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: UDI-DI: 00357599818005. Lot/Serial Numbers: T60001948/0FP5Z6330 0FP5Z633C 0FP5Z90AF 0FP5Z90AL 0FP5Z90AR 0FP5Z90AX 0FP5Z90AZ 0FP5Z90C0 0FP5Z90C1 0FP5Z90C2 0FP5Z90C3 0FP5Z90C4 0FP5Z90C5 0FP5Z90C6 0FP5Z90C7 0FP5Z90C8 0FP5Z90CA 0FP5Z90CC 0FP5Z90CD 0FP5Z90CE 0FP5Z90CF 0FP5Z90J1 0FP5Z90J2 0FP5Z90J3 0FP5Z90J4 0FP5Z90J5 0FP5Z90J6 0FP5Z90J7 0FP5Z90J8 0FP5Z90J9 0FP5Z90JA 0FP5Z90JC 0FP5Z90JE 0FP5Z90JF 0FP5Z90JG 0FP5Z90JH 0FP5Z90JJ 0FP5Z90JK 0FP5Z90JM 0FP5Z90JN 0FP5Z90JR 0FP5Z90JT 0FP5Z90JU 0FP5Z90JX 0FP5Z90K0 0FP5Z90K2 0FP5Z90K3 0FP5Z90K4 0FP5Z90K5 0FP5Z90K6 0FP5Z90K7 0FP5Z90K8 0FP5Z90K9 0FP5Z90KC 0FP5Z90KD 0FP5Z90KE 0FP5Z90KF 0FP5Z90KG 0FP5Z90KH 0FP5Z90KJ 0FP5Z90KL 0FP5Z90KM 0FP5Z90KP 0FP5Z90KQ 0FP5Z90KR 0FP5Z90KT 0FP5Z90KU 0FP5Z90KV 0FP5Z90KW 0FP5Z90KY 0FP5Z90KZ 0FP5Z90L0 0FP5Z90L2 0FP5Z90L4 0FP5Z90L5 0FP5Z90L6 0FP5Z90L7 0FP5Z90L9 0FP5Z90LA 0FP5Z90LC 0FP5Z90LD 0FP5Z90T2 0FP5Z90T4 0FP5Z90T6 0FP5Z90T8 0FP5Z90T9 0FP5Z90TA 0FP5Z90TC 0FP5Z90TD 0FP5Z90TE 0FP5Z90TF 0FP5Z90TG 0FP5Z90TH 0FP5Z90TK 0FP5Z90TL 0FP5Z90TP 0FP5Z90TQ 0FP5Z90TR 0FP5Z90TT 0FP5Z90TU 0FP5Z90TW 0FP5Z90TX 0FP5Z90TY 0FP5Z90TZ 0FP5Z90U1 0FP5Z90U2 0FP5Z90U4 0FP5Z90U5 0FP5Z90U6 0FP5Z90U8 0FP5Z90UA 0FP5Z90UD 0FP5Z90UE 0FP5Z90UF 0FP5Z90UG 0FP5Z90UH 0FP5Z90UJ 0FP5Z90UK 0FP5Z90UL 0FP5Z90UM 0FP5Z90UN 0FP5Z90UP 0FP5Z90UQ 0FP5Z90UR 0FP5Z90UT 0FP5Z90UU 0FP5Z90UV 0FP5Z90UW 0FP5Z90UX 0FP5Z90UZ 0FP5Z90V0 0FP5Z90V1 0FP5Z90V2 0FP5Z90V3 0FP5Z90V4 0FP5Z90V5 0FP5Z90V6 0FP5Z90V7 0FP5Z90V8 0FP5Z90V9 0FP5Z90VA 0FP5Z90VC 0FP5Z9114 0FP5Z9115 0FP5Z9116 0FP5Z9117 0FP5Z9118 0FP5Z9119 0FP5Z911C 0FP5Z911D 0FP5Z911E 0FP5Z911F 0FP5Z911J 0FP5Z911K 0FP5Z911L 0FP5Z911M 0FP5Z911N 0FP5Z911Q 0FP5Z911R 0FP5Z911T 0FP5Z911U 0FP5Z911V 0FP5Z911W 0FP5Z911X 0FP5Z911Y 0FP5Z911Z 0FP5Z9120 0FP5Z9122 0FP5Z9123 0FP5Z9124 0FP5Z9125 0FP5Z9126 0FP5Z9127 0FP5Z912C 0FP5Z912E 0FP5Z912F 0FP5Z912G 0FP5Z912H 0FP5Z912J 0FP5Z912P 0FP5Z912Q 0FP5Z912T 0FP5Z912X 0FP5Z912Y 0FP5Z912Z 0FP5Z9130 0FP5Z9133 0FP5Z9134 0FP5Z9136 0FP5Z9138 0FP5Z9139 0FP5Z9196 0FP5Z9197 0FP5Z9198 0FP5Z9…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY
      status: recorded

FDA recall Z-2692-2024: Abbott Diabetes Care, Inc. is recalling FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
type: Claim
text: The FDA logged enforcement record Z-2692-2024: Abbott Diabetes Care, Inc. is voluntarily recalling FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System — reason: Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-07-24. Affected lots/codes: UDI-DI: 00357599818005. Lot/Serial Numbers: T60001948/0FP5Z6330 0FP5Z633C 0FP5Z90AF 0FP5Z90AL 0FP5Z90AR 0FP5Z90AX 0FP5Z90AZ 0FP5Z90C0 0FP5Z90C1 0FP5Z90C2 0FP5Z90C3 0FP5Z90C4 0FP5Z90C5 0FP5Z90C6 0FP5Z90C7 0FP5Z90C8 0FP5Z90CA 0FP5Z90CC 0FP5Z90CD 0FP5Z90CE 0FP5Z90CF 0FP5Z90J1 0FP5Z90J2 0FP5Z90J3 0FP5Z90J4 0FP5Z90J5 0FP5Z90J6 0FP5Z90J7 0FP5Z90J8 0FP5Z90J9 0FP5Z90JA 0FP5Z90JC 0FP5Z90JE 0FP5Z90JF 0FP5Z90JG 0FP5Z90JH 0FP5Z90JJ 0FP5Z90JK 0FP5Z90JM 0FP5Z90JN 0FP5Z90JR 0FP5Z90JT 0FP5Z90JU 0FP5Z90JX 0FP5Z90K0 0FP5Z90K2 0FP5Z90K3 0FP5Z90K4 0FP5Z90K5 0FP5Z90K6 0FP5Z90K7 0FP5Z90K8 …
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-2692-2024 as Class I
type: Claim
text: The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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 I
  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.