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PCRopsis RVD Reagent (Entopsis) - Label Misleading (2023)

Presence of misleading label statements on the product label.

FDAFeb 21, 2023Nationwide• Entopsis Inc.

Carto Vizigo Guiding Sheath (Biosense Webster) - Incorrect Labeling (2023)

Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch

Low

FDAFeb 21, 2023Nationwide• Biosense Webster, Inc.

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PCRopsis RVD Reagent (Entopsis) - Label Misleading (2023)

Carto Vizigo Guiding Sheath (Biosense Webster) - Incorrect Labeling (2023)

PCRopsis Buccal Reagent (Entopsis) - Label Misleading (2023)

PCRopsis Support (Entopsis) - Label Misleading (2023)

BioPlex 2200 Calibrator Set (Bio-Rad) - Result Discrepancy (2023)

PCRopsis BCSNano (Entopsis) - Label Misleading (2023)

Moberg CNS Monitor (Moberg) - Battery Leakage (2023)

2D Perfusion (Philips) - Signal Processing (2023)

SmartPerfusion (Philips) - Signal Processing (2023)

Arjo Portable Scale Adaptor (Arjohuntleigh) - Strap Detachment (2023)

Raystation Treatment Planning (RaySearch) - Collimator Angle (2023)

Agilent Resolution Kit (Agilent) - Instruction Issue (2023)

Thermage CPT System (Solta Medical) - Calibration Problem (2023)

Infinity Occipitocervical Screw (Medtronic) - Material Strength (2023)

KLS Martin Battery Pack (Pro-Dex) - Expiration Mixup (2023)

FoundationOne CDx (Foundation Medicine) - Claim Error (2023)

Flex-Neck Catheter Kit (Merit) - Unintended Distribution (2023)

Attune Revision Tibial Insert (DePuy) - Irradiation Dosage (2023)

Attune Posterior Tibial Insert (DePuy) - Irradiation Dosage (2023)

BD Pyxis MedStation Tower (CareFusion) - Door Latch Failure (2023)