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RX Imola Analyzer (Randox) – Rerun Setting Failure (2023)

RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when incorrectly. Potential to report incorrectly.

Moderate

FDASep 6, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

Moderate

FDASep 6, 2023Nationwide

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RX Imola Analyzer (Randox) – Rerun Setting Failure (2023)

RX Modena Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

BD Pyxis CII Safe (CareFusion) – Formulary Update Issue (2023)

RX Monaco Analyzer (Randox) – Rerun Setting Failure (2023)

RSP Glenoid Baseplate (Unknown) – Coating Engagement (2023)

Meera Mobile Operating Table (Getinge) – Control Unit Problem (2023)

2008T Hemodialysis System w/Bibag (Fresenius) – PCBA leaching risk (2023)

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Hemodialysis System (Fresenius) – Tubing Leaching (2023)

Portex Pro-Vent Arterial Blood Sampling Kit (Smiths Medical) – component missing (2023)

2008T Hemodialysis System without CDX (Fresenius) – PCBA leaching risk (2023)

AU/DxC Chemistry Transferrin (Beckman Coulter) – stability claims issue (2023)

RX Daytona Plus Clinical Chemistry Analyzer (Randox) – rerun settings issue (2023)

Zimmer Dermatome Blades (Zimmer Surgical) – skin graft quality issue (2023)

Oasis Dry Suction Water Seal Chest Drain (Atrium) – unauthorized reprocessing (2023)

MAZOR X Robotic Guidance System (Unknown) – software update (2023)

Male-Female Midsection (Onkos Surgical) – Tyvek seal breach (2023)

CVS PCSU SJH Pack (American Contract) – component investigation (2023)

Vasc. Open CVOR SJH Pack (American Contract) – component investigation (2023)

Robotics Pack SAH (American Contract) – component investigation (2023)