FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
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.
openFDA drug & device enforcement (recall) reports
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
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 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 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A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
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
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.
U.S. FDA recall classification (openFDA enforcement)
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.
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.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
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.
Ongoing — the recall is still being carried out.
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.
US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY