FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Published September 4, 2024 · Recall initiated: July 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Diabetes Care, Inc.
- Distributor
- US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY
- Lot
- 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 0FP5Z919A 0FP5Z919C 0FP5Z919E 0FP5Z919F 0FP5Z919G 0FP5Z919J 0FP5Z919K 0FP5Z919L 0FP5Z919M 0FP5Z919N 0FP5Z919Q 0FP5Z919R 0FP5Z919X 0FP5Z919Z 0FP5Z91A0 0FP5Z91A1 0FP5Z91A2 0FP5Z91A3 0FP5Z91A4 0FP5Z91A5 0FP5Z91A6 0FP5Z91A7 0FP5Z91A8 0FP5Z91A9 0FP5Z91AA 0FP5Z91AC 0FP5Z91AE 0FP5Z91AG 0FP5Z91AH 0FP5Z91AJ 0FP5Z91AK 0FP5Z91AL 0FP5Z91AM 0FP5Z91AP 0FP5Z91AQ 0FP5Z91AR 0FP5Z91AU 0FP5Z91AW 0FP5Z91AX 0FP5Z91AY 0FP5Z91AZ 0FP5Z91C0 0FP5Z91C1 0FP5Z91C2 0FP5Z91C3 0FP5Z91C4 0FP5Z91C7 0FP5Z91C8 0FP5Z91JR 0FP5Z91JV 0FP5Z91JX 0FP5Z91JY 0FP5Z91JZ 0FP5Z91K0 0FP5Z91K1 0FP5Z91K2 0FP5Z91K4 0FP5Z91K5 0FP5Z91K6 0FP5Z91K7 0FP5Z91K8 0FP5Z91K9 0FP5Z91KA 0FP5Z91KC 0FP5Z91KD 0FP5Z91KE 0FP5Z91KF 0FP5Z91KG 0FP5Z91KH 0FP5Z91KJ 0FP5Z91KK 0FP5Z91KL 0FP5Z91KM 0FP5Z91KN 0FP5Z91KP 0FP5Z91KQ 0FP5Z91KR 0FP5Z91KT 0FP5Z91KU 0FP5Z91KX 0FP5Z91KY 0FP5Z91KZ 0FP5Z91L1 0FP5Z91L4 0FP5Z91L5 0FP5Z91L6 0FP5Z91TP 0FP5Z91U1 0FP5Z91U6 0FP5Z91U7 0FP5Z91UC 0FP5Z91UD 0FP5Z91UH 0FP5Z91UJ 0FP5Z91UN 0FP5Z91UX 0FP5Z91UY 0FP5Z91UZ 0FP5Z921D 0FP5Z921E 0FP5Z921G 0FP5Z921K 0FP5Z921M 0FP5Z921N 0FP5Z921P 0FP5Z921Q 0FP5Z921R 0FP5Z921T 0FP5Z921U 0FP5Z921V 0FP5Z921W 0FP5Z921X 0FP5Z921Y 0FP5Z921Z 0FP5Z9220 0FP5Z9221 0FP5Z9222 0FP5Z9223 0FP5Z9224 0FP5Z9225 0FP5Z9226 0FP5Z9228 0FP5Z922E 0FP5Z922J 0FP5Z922L 0FP5Z922M 0FP5Z922V 0FP5Z922W 0FP5Z9230 0FP5Z9231 0FP5Z929K 0FP5Z929L 0FP5Z929M 0FP5Z929N 0FP5Z929P 0FP5Z929Q 0FP5Z929R 0FP5Z929T 0FP5Z929X 0FP5Z929Y 0FP5Z929Z 0FP5Z92A0 0FP5Z92A3 0FP5Z92A4 0FP5Z92A8 0FP5Z92AA 0FP5Z92AD 0FP5Z92AE 0FP5Z92AH 0FP5Z92AJ 0FP5Z92AL 0FP5Z92AN 0FP5Z92JN 0FP5Z92JR 0FP5Z92JT 0FP5Z92JW 0FP5Z92TN 0FP5Z92TP 0FP5Z92TQ 0FP5Z92TR 0FP5Z92TV 0FP5Z92TW 0FP5Z92TX 0FP5Z92U7 0FP5Z92UD 0FP5Z92UJ 0FP5Z92UK 0FP5Z92UL 0FP5Z92UM 0FP5Z92UN 0FP5Z9324 0FP5Z9326 0FP5Z9327 0FP5Z932C 0FP5Z932D 0FP5Z932G 0FP5Z932H 0FP5Z932J 0FP5Z932K 0FR4J6414 0FR4J6416 0FR4J641G 0FR4J641M 0FR4J641N 0FR4J641R 0FR4J641U 0FR4J641V 0FR4J641Y 0FR4J641Z 0FR4J6420 0FR4J642A 0FR4J648U 0FR4J648Z 0FR55D9HC 0FR55D9HD 0FR55D9HE 0FR55D9HG 0FR55D9HK 0FR55D9HL 0FR55D9HM 0FR55
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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