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DxI 9000 Access Analyzer (Beckman Coulter) – Software Update Error (2025)

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

Moderate

FDAApr 23, 2025Nationwide• Beckman Coulter, Inc.

Palindrome HSI Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Potential breach of sterile barrier packaging.

High

FDAApr 23, 2025Nationwide• Mozarc Medical US LLC

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DxI 9000 Access Analyzer (Beckman Coulter) – Software Update Error (2025)

Palindrome HSI Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Palindrome Precision Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

Apo B Reagent (Beckman Coulter) – Calibration Error (2025)

Mahurkar Hemodialysis Catheter (Mozarc) – Sterility Breach (2025)

3M Ranger Irrigation Set (3M) – Flow Rate Clarification (2025)

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Endopath Echelon Vascular Reload (Ethicon) – Instrument Lockout (2025)

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Codman Disposable Perforator Kit (Medline) – Weld Inadequacy (2025)

Catalyst+ C4D Software (C-RAD) – Scanning Equipment Error (2025)

Lower Extremity Implant (American Contract) – EO/ECH Residuals (2025)

BD Cathena IV Catheter (BD) – Septum Defect Risk (2025)

Precision Sampling Set (Capnia) – Contamination Risk (2025)

Bard Intragastric Balloon Tube (C.R. Bard) – Plug Removal (2025)

Bard Minnesota Tamponade Tube (C.R. Bard) – Plug Removal (2025)

Bard Blakemore Tube (C.R. Bard) – Plug Removal Issue (2025)

Check=Flo Introducer (Cook) – Sizing Error (2025)

Straumann Healing Abutment (Straumann) – Blister Labeling (2025)

Tornado Embolization Microcoil (Cook) – Sizing Error (2025)