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UniCel DxH 900 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Moderate

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

UniCel DxH 690T Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.

Moderate

FDAAug 13, 2025Nationwide• Beckman Coulter Inc.

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UniCel DxH 900 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

UniCel DxH 690T Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Tuscan Artichoke Salad (Fresh & Ready) – undeclared allergens (2025)

Spanish Club Ciabatta (Fresh & Ready) – undeclared allergens (2025)

Chili Crunch Mezze (Fresh & Ready) – wheat allergen (2025)

Ciprofloxacin Dexamethasone Otic Suspension (Sandoz) - Temperature Abuse (2025)

UniCel DxH 600 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Philips CT System (Philips) – Patient Table Descent Risk (2025)

Piccolo Pranzo Box (Fresh & Ready) – undeclared allergens (2025)

Blueberry Pretzels (HEB) – wheat allergen (2025)

UniCel DxH 800 Analyzer (Beckman Coulter) – Hemoglobin Result Error (2025)

Change Healthcare Radiology Software (Change Healthcare) – Report Display Issue (2025)

Smart Drive MX2+ Wheelchair Control (Max Mobility) – Speed Control Risk (2025)

NutraGlide Nasal Feeding Tube (Applied Medical) – Tip Detachment Risk (2025)

Artis Pheno X-Ray System (Siemens) – Limited System Movement (2025)

Everything Bagel Mix (Bakers Authority) – undeclared allergens (2025)

Three Seed Mix (Bakers Authority) – undeclared allergens (2025)

Pure Cane Sugar (Domino) – foreign object contamination (2025)

Frozen Shrimp in Bulk Packaging (H & N Group) – Cesium-137 risk (2025)

Quesito Colombian Cheese (El Establo) – Listeria risk (2025)