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BD MAX SARS-CoV-2 Reagents (Becton Dickinson) – False Negative Risk (2024)

Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.

FDAMay 7, 2024Nationwide• Becton Dickinson & Co.

CORI Surgical System (Blue Belt) – Marker Registration Error (2024)

CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay

Moderate

FDAMay 7, 2024Nationwide• Blue Belt Technologies, Inc

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BD MAX SARS-CoV-2 Reagents (Becton Dickinson) – False Negative Risk (2024)

CORI Surgical System (Blue Belt) – Marker Registration Error (2024)

Losartan Hydrochlorothiazide (Macleods) – Plastic Contamination (2024)

Zilretta Injection (Pacira) – Stability Specification Failure (2024)

Cataract Pack Kit (American Contract Systems) – Sterilization Issue (2024)

NovaGuide 2 Ultrasound (NovaSignal) – Electrical Shock Risk (2024)

Hiniker 700 Series Snowplow (Hiniker) – Electrical System Problem (2024)

Autocar Legend Truck (Autocar) – Wiring Harness Risk (2024)

Hand Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Biopsy Drape Pack (American Contract Systems) – Sterilization Issue (2024)

Gyn Laparoscopy Kit (American Contract Systems) – Sterilization Issue (2024)

Legend Revo ARC Suspension (Legend) – Reservoir Defect (2024)

Special Procedure Pack (American Contract Systems) – Sterilization Issue (2024)

Spine Pack Kit (American Contract Systems) – Sterilization Issue (2024)

Phoenix Shuttle Bus (Coach and Equipment) – Seat Safety (2024)

Extremity Convenience Kit (American Contract Systems) – Sterilization Issue (2024)

NovaGuide 2 Traditional Ultrasound (NovaSignal) – Electrical Shock Risk (2024)

Laparoscopy Litho Pack (American Contract Systems) – Sterilization Issue (2024)

Mercedes-Benz eSprinter (Mercedes-Benz) – Electronic Stability Issue (2024)

Metoprolol Tablets (Rubicon) – Metal Contamination (2024)