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nanoDot D2DNS Screened QC (Unknown) – Accuracy Range Issue (2023)

LANDAUER received reports indicating that some nanoDots may potentially be outside of the specified range of +/-5.5% accuracy. Investigation of nanoDots indicated the presence of a potential non-conformance in the Optical Stimulated Luminescence (OSL) material that is beamed after exposure and emits fluorescence proportional to radiation exposure.

Moderate

FDAJul 12, 2023Nationwide

nanoDot D2DNS Calibrate Screened (Unknown) – Accuracy Range Issue (2023)

Moderate

FDAJul 12, 2023Nationwide

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nanoDot D2DNS Screened QC (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DNS Calibrate Screened (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DNN Constancy (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DNS Calibrate Screened (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DNS QC Screened (Unknown) – Accuracy Range Issue (2023)

NanoDots QC Set (Unknown) – Accuracy Range Issue (2023)

Air/Water Valve (Olympus) – Valve Functionality Loss (2023)

nanoDot C - item 3 of 3 for 03500-000, Model Number 03503... – landauer received reports indicating ... (2023)

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753,... (Medicrea International Vancia Vancia Rillieux La Pape France) – there is a potential for a product pa... (2023)

Carina Sub-Acute Care Ventilator (Draeger Medical, Inc.) – presence of polyether polyurethane (p... (2023)

The following Pro.specta Emission Computed Tomography Sys... (Siemens Medical Solutions USA, Inc.) – during a whole-body planar scan with ... (2023)

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K (Medtronic Sofamor Danek USA, Inc) – incorrect laser marking - solera awl ... (2023)

GRANVIA-C (Medicrea) – Packaging Pinhole Issue (2023)

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

nanoDot D2DNN (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DXN (Unknown) – Accuracy Range Issue (2023)

nanoDot D2DNS Custom (Unknown) – Accuracy Range Issue (2023)

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

nanoDot D2DNS QC (Unknown) – Accuracy Range Issue (2023)

nanoDot Adapter (Unknown) – Accuracy Range Issue (2023)