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IMMULITE 2000 PTH Assay (Siemens) – result inaccuracy (2025)

The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on the IMMULITE 2000/IMMULITE 2000 XPi systems. The bias is observed in both serum and plasma samples.

Moderate

FDASep 22, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Virata Preassembled Polyaxial Screw (Orthofix) – Performance Standard Failure (2025)

Polyaxial screws do not meet performance standards.

Low

FDASep 19, 2025Nationwide• Orthofix U.S. LLC

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IMMULITE 2000 PTH Assay (Siemens) – result inaccuracy (2025)

Virata Preassembled Polyaxial Screw (Orthofix) – Performance Standard Failure (2025)

ARVIS Shoulder System (Kico) – surgical planning flaw (2025)

DxI 9000 Immunoassay Analyzer (Beckman) – result accuracy issue (2025)

DxC 500i Clinical Analyzer (Beckman) – result accuracy issue (2025)

Alinity hq Analyzer (Abbott) – Result Flagging Issue (2025)

LOGIQ P9 Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

HeartSine Pad-Pak (HeartSine) – Defibrillator Pin Damage (2025)

Zenith Alpha 2 Thoracic Graft (Cook Medical) – PTFE Coating Risk (2025)

LOGIQ P10 Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

Salem Sump PVC Tubes (Cardinal Health) – Valve Breakage Risk (2025)

LOGIQ P10 HD Ultrasound (GE Medical) – Measurement Inaccuracy (2025)

Pain Management Tray (B Braun) – Catheter Connector Misalignment (2025)

PERIFIX Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

ESPOCAN Spinal Epidural Tray (B Braun) – Connector Position Problem (2025)

Airvo 2 (Fisher & Paykel) – Power Disconnection Risk (2025)

PERIFIX FX Epidural Tray (B Braun) – Connector Position Issue (2025)

PERIFIX FX Epidural Tray (B Braun) – Catheter Connector Issue (2025)

MOSAIQ Oncology System (Elekta) – Care Plan Order Error (2025)

Phasitron 5 IPV Valve (Percussionaire) – Leak and Usage Warning (2025)