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Atellica IM Cortisol Test (Siemens) – urine sample bias (2023)

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Moderate

FDAMar 16, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Integre Pro Laser Device (Ellex) – beam scattering risk (2023)

Fire/Burn Risk

When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery device, a scattered laser beam inside the laser cavity system may unintentionally exit through the Slit Lamp output port (SDS) and get emitted from the Objective Lens when the laser is fired.

High

FDAMar 16, 2023Nationwide• Ellex Medical Pty Ltd.

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Atellica IM Cortisol Test (Siemens) – urine sample bias (2023)

Integre Pro Laser Device (Ellex) – beam scattering risk (2023)

ADVIA Centaur Cortisol Test (Siemens) – urine sample bias (2023)

JULIET Lumbar Plate (SpineArt) – potential disassembly (2023)

Doxazosin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Atorvastatin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Epinephrine Kit (Focus Health Group) – Incorrect Labeling (2023)

BusPIRone Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

Beckman Coulter Access Free T3 (Beckman Coulter) – test result issue (2023)

Hamilton-C6 Ventilator (Hamilton Medical) – safety ventilation error (2023)

Pantoprazole Tablets (Hetero USA) – Discoloration Issue (2023)

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

Atovaquone Oral Suspension 750mg (Camber) – Microbial Contamination (2023)

VITROS XT 7600 Integrated System (Ortho-Clinical Diagnostics) – MicroTip Pack Issue (2023)

MAKO RESTORIS MCK Baseplate Trial (Stryker) – Incorrect Size Marking (2023)