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SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.

Moderate

FDASep 17, 2025Nationwide• Beckman Coulter Inc.

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

FDASep 17, 2025MO• Park Avenue Compounding

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SYNCHRON LDL Cholesterol Reagent (Beckman Coulter) – Test Accuracy Issue (2025)

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

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

Oral Probe (Baxter) – Temperature Reading Error (2025)

Fuse ULTRA Foot Plating System (CPM Medical) – Sterilization Update (2025)

BrainSTORM Surgical Planner (Surgical Theater) – Image Alignment Issue (2025)

Levothyroxine Tablets (Accord) – Subpotent Medication (2025)

Surgical Navigation Platform (Surgical Theater) – Image Misalignment Risk (2025)

Shrimp Cocktail Bowl (Lawrence Wholesale) – Cesium Risk (2025)

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Endo Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

Sweet Potato Baby Food (Sprout Organics) – Lead Contamination (2025)

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Surgical Planner (Surgical Theater) – Image Fusion Misalignment (2025)

ZF Transmission Control Unit (ZF) – Transmission Issue (2025)

SpineAR Surgical Navigation (Surgical Theater) – Image Fusion Problem (2025)

SyncAR Surgical Navigation (Surgical Theater) – Image Fusion Misalignment (2025)

Impella Controller (Abiomed) – Purge Pressure Problem (2025)