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BIOFIRE Gastrointestinal Panel – False Negative Results (2023)

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Moderate

FDANov 27, 2023CA, CT, FL +13 more• BioFire Diagnostics, LLC

Captus 4000e Thyroid Uptake System – Spring Arm Failure (2023)

Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator

Moderate

FDANov 27, 2023Nationwide• Mirion Technologies (Capintec), Inc.

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BIOFIRE Gastrointestinal Panel – False Negative Results (2023)

Captus 4000e Thyroid Uptake System – Spring Arm Failure (2023)

VITROS Anti-HBs Quantitative Reagent – Calibration Failures (2023)

BIOFIRE Respiratory Panel – False Negative Results (2023)

RibLoc U Plus 90 Instrument – Potential Breakage (2023)

Actim PROM Dipstick – Lubricant Interference (2023)

Fujifilm Mobile X-Ray System – Incorrect Default Settings (2023)

DeRoyal Cardiac Cath Kit – Recalled Transducer (2023)

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Exactech Equinoxe Reverse Shoulder System – Vacuum Bag Loss (2023)

Exactech Novation Hip System – Vacuum Bag Loss (2023)

Exactech Optetrak Logic Knee System – Vacuum Bag Loss (2023)

Exactech Vantage Ankle System – Vacuum Bag Loss (2023)

QMS Tacrolimus Calibrators – Improper Storage (2023)

DxI 9000 Access Immunoassay Analyzer – Performance Issues (2023)

Exactech Alteon Hip XLE Liner – Vacuum Bag Loss (2023)

Access Ultrasensitive Insulin – Assay Protocol Issue (2023)

Exactech Truliant Knee System – Vacuum Bag Loss (2023)

Exactech Equinoxe Shoulder System – Vacuum Bag Loss (2023)

Exactech Truliant Knee Insert – Vacuum Bag Loss (2023)