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

Presence of misleading label statements on the product label.

FDAFeb 21, 2023Nationwide• Entopsis Inc.

Neodent GM X Titanium Base (Preat) - Movement Issue (2023)

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

High

FDAFeb 21, 2023Nationwide• Preat Corp

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

Neodent GM X Titanium Base (Preat) - Movement Issue (2023)

PCRopsis BCSNano (Entopsis) - Label Misleading (2023)

BioPlex 2200 Reagent Pack (Bio-Rad) - Result Discrepancy (2023)

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

PCRopsis Support (Entopsis) - Label Misleading (2023)

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

SmartPerfusion (Philips) - Signal Processing (2023)

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

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

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

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

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

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

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

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

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

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

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

BD Pyxis MedStation (CareFusion) - Drawer Failure (2023)