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FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2 app, or the sensor's full wear time hasn't ended, users may be unable to start a new sensor, which could result in no or delayed glucose results

Moderate

FDAJul 12, 2023Nationwide• Abbott Diabetes Care, Inc.

2023 BMW 760I – bmw of north america, llc (bmw) is re... (2023)

BMW of North America, LLC (BMW) is recalling certain 2023 740i, 760i xDrive and i7 xDrive60 vehicles equipped with an Interaction Bar. The Interaction Bar, located on the dashboard, may not activate the windshield defrosting/defogging system and/or the hazard warning lights. In addition, those control buttons may not illuminate when pressed. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 103, "Windshield Defrosting and Defogging Systems", and 108, "Lamps, Reflective Devices, and Associated Equipment."

High

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FreeStyle Libre 2 Readers (Abbott) – Sensor Start Issue (2023)

2023 BMW 760I – bmw of north america, llc (bmw) is re... (2023)

2023 NOVA BUS LFS – nova bus (us) inc (2023)

IMPIX ALIF (Medicrea) – Packaging Pinhole Issue (2023)

IMPIX ALIF S/A (Medicrea) – Packaging Pinhole Issue (2023)

IMPIX DLIF (Medicrea) – Packaging Pinhole Issue (2023)

IMPIX C+ (Medicrea) – Packaging Pinhole Issue (2023)

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x (Beckman Coulter Inc.) – lipemic interference failed to meet t... (2023)

2021 PREVOST X3-45 COMMUTER – prevost car (us) inc (2023)

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Imp... (Boston Scientific Corporation) – there is a potential for a rare inter... (2023)

SEATS SEAT – fall hazard (2023)

2023 TOYOTA RAV4 – gulf states toyota, inc (2023)

Oxacillin Injection (Sagent) – sterility issue (2023)

Oxacillin Injection (Sagent) – sterility risk (2023)

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Oxacillin Injection (Sagent) – Sterility Concern (2023)

2022 PREVOST H3-45 VIP – prevost car (us) inc (2023)

Atellica CH HDL Cholesterol- In vitro diagnostic use in ... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)