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Nova Prime Plus Analyzer (Nova Biomedical) – Creatinine Results (2023)

Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

Moderate

FDASep 18, 2023Nationwide• Nova Biomedical Corporation

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

Moderate

FDASep 18, 2023Nationwide

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Nova Prime Plus Analyzer (Nova Biomedical) – Creatinine Results (2023)

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

BD Alaris PCU (CareFusion) – Syringe Validation (2023)

Alaris PCA Module (CareFusion) – Syringe Validation (2023)

BD Alaris Syringe Module (CareFusion) – Syringe Validation (2023)

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Aptima CMV Quant Assay (Hologic) – Sample Error (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

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Centricity Universal Viewer (GE Healthcare) – Image Mixing (2023)

Centricity PACS-IW (GE Healthcare) – Image Mixing (2023)

Maquet Acrobat-i Stabilizer (Maquet) – Housing Mount Failure (2023)

Astral Ventilators (Unknown) – Battery Alarm Fault (2023)

Breg Walker (Breg) – Misaligned Wheels (2023)

Stryker Portal Entry Kit (Stryker) – Expired Product (2023)

Monoject Tuberculin Syringe (Cardinal Health) – Tip Compatibility (2023)

Thunderbeat Surgical Device (Olympus) – Button Malfunction (2023)

Cios Alpha C-arm (Siemens) – Software Update (2023)

RayCare (RaySearch) – Document Visibility Issue (2023)

Cios Flow C-arm (Siemens) – Software Update (2023)