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ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

Moderate

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Moderate

FDAApr 15, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

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ADVIA Centaur Calibrator (Siemens) – Reference Interval (2025)

Atellica Homocysteine Calibrator (Siemens) – Reference Interval (2025)

Straumann Initial Drill (Straumann) – Laser Engraving (2025)

Glidewell HT Implant Drill (Prismatik) – Packaging Mixup (2025)

Augmedics Perc Pin Adaptor (Augmedics) – Tightening Marking (2025)

VITROS Chemistry CRP Slides (Ortho-Clinical) – Labeling Error (2025)

Microtek Patient Drape (Microtek) – Sterility Concern (2025)

Pruitt Occlusion Catheter (LeMaitre) – Seal Integrity (2025)

TufTex Embolectomy Catheter (LeMaitre) – Seal Integrity (2025)

MedicaLyte Bicarbonate (Nipro) – Foreign Matter Risk (2025)

Codman Disposable Perforator (Integra) – Weld Integrity (2025)

Pruitt Irrigation Catheter (LeMaitre) – Seal Integrity (2025)

iGo2 DC Car Adapter (Medical Depot) – Power Supply Risk (2025)

Codman Craniotomy Kit (Integra) – Weld Integrity (2025)

Centerline IOPS Guidewire (Centerline) – Coating Failure (2025)

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

CMS8000 Patient Monitor (Contec) – Cybersecurity Risk (2025)

3M Ranger Blood Warming Set (3M) – Flow Rate Clarification (2025)

Blueprint Software (Tornier) – Case Access Issue (2025)

CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)