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Atellica CH Toxicology Calibrator (Siemens) – Calibration Reassignment (2023)

Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

Low

FDAApr 5, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

UA WIN 10 Kit (Beckman Coulter) – Flag Display Concern (2023)

Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

Low

FDAApr 5, 2023Nationwide• Beckman Coulter, Inc.

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Atellica CH Toxicology Calibrator (Siemens) – Calibration Reassignment (2023)

UA WIN 10 Kit (Beckman Coulter) – Flag Display Concern (2023)

WATCHDOG Hemostasis Valve Kit (Boston Scientific) – Insertion Tool Occlusion (2023)

Draeger Infinity CentralStation (Draeger) – Waveform Peak Dropping (2023)

ADVIA Chemistry ToxAmmonia Calibrator (Siemens) – Calibration Reassignment (2023)

DxU 850m Iris Urine Analyzer (Beckman Coulter) – Flag Display Issue (2023)

DxU 840m Iris Urine Analyzer (Beckman Coulter) – Flag Display Problem (2023)

BD Pyxis MedStation (CareFusion) – Medication Order Issue (2023)

Draeger Infinity M300 (Draeger) – Waveform Peak Dropping (2023)

iQ200 Series Urine Analyzer (Beckman Coulter) – Flag Display Issue (2023)

Karl Storz Radel Sterilization Tray (Karl Storz) – Instructions Update (2023)

Beckman Coulter Bicarbonate (Beckman Coulter) – Calibration Problem (2023)

DuraLife Silicone Extension Tube (Smiths Medical) – Sterilization Risk (2023)

MAQUET CARDIOSAVE IABP (Datascope) – Power Cord Incompatibility (2023)

GEO Instrument Kit (Gramercy) – Drill Guide Depth Error (2023)

Olympus Ultrasound Needle (Olympus) – Needle Angle Nonconformance (2023)

ProSun Luxura Vegaz (J & T Health) – Safety Circuit Disturbance (2023)

Pilot COVID-19 At-Home Test (SD Biosensor) – Buffer Contamination (2023)

PDS Plus Antibacterial Suture (Ethicon) – Breakage Risk (2023)

ViziShot 2 Aspiration Needle (Olympus) – Needle Angle Nonconformance (2023)