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Dimension Vista Magnesium Flex (Siemens) – Reagent Imprecision (2022)

Dimension Vista Magnesium Flex reagent cartridge lots exhibiting imprecision and intermittent Abnormal Assay flags. When this issue occurs, there is a potential for QC failures or erroneous patient results which may lead to repeat and follow-up testing.

FDAJan 28, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

HeartWare VAD System (Heartware) – Cleaning Instructions (2022)

Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.

FDAJan 27, 2022Nationwide• Heartware, Inc.

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Dimension Vista Magnesium Flex (Siemens) – Reagent Imprecision (2022)

HeartWare VAD System (Heartware) – Cleaning Instructions (2022)

Bard SureStep Catheter (C.R. Bard) – Potential Leakage (2022)

MiniMed Insulin Pump (Medtronic) – Incorrect Pre-Programming (2022)

UV-C Germicidal Wand (In My Bathroom) – Radiation Excess (2022)

Panther Fusion Extraction Reagent (Hologic) – Stability Failure (2022)

IntraSight Mobile IVUS Systems (Volcano) – Control Unit Issue (2022)

Philips Respironics V60 Ventilator (Respironics) – Adhesive Failure (2022)

Arterial Line Kit (Argon Medical) – Guidewire Compatibility (2022)

Philips Respironics V60 Plus Ventilator (Respironics) – Adhesive Failure (2022)

Matrix Clinical Solution COVID-19 Test (Matrix Medical) – Home Collection Unauthorized (2022)

NeuMoDx Flu Test Strip (NeuMoDx) – Contamination Risk (2022)

Footrest (NRT X-Ray) – Clamping Mechanism Issue (2022)

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

Lumbar Puncture Tray Adult (Bard) – Manometer Failure (2022)

YelloPort Plus Cannula (Surgical Innovations) – Sterility Labeling (2022)

Atraumatic Lumbar Puncture Tray (Bard) – Manometer Failure (2022)

Lumbar Puncture Drug Free Tray (Bard) – Manometer Failure (2022)

Tablo Console (Outset Medical) – Heat Damage Risk (2022)

Sight OLO Blood Analysis Device (Sight Diagnostics) – Reference Range Issue (2022)