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

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Moderate

FDAJul 12, 2023Nationwide• Medicrea International Vancia Vancia Rillieux La Pape France

nanoDot B (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

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

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

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

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

NanoDots (Unknown) – Accuracy Range Issue (2023)

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

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

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

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

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

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

nanoDot D2DNN Constancy (Unknown) – Accuracy Range 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)

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)

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

Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnost... (Siemens Healthcare Diagnostics, Inc.) – potential for reagent carryover on th... (2023)

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

SurgiCount+ Software Application-indicated as an adjuncti... (Stryker Corporation) – potential for current software to mis... (2023)