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Showing 10301–10320 of 11714 results

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Radiometer Medical ApS Akandevej 21 Bronshoj Denmark: E3800 PC Units (spare parts)

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

FDAApr 14, 2021Nationwide• Radiometer Medical ApS Akandevej 21 Bronshoj Denmark

Boston Scientific Corporation: VICI VENOUS STENT System Product Usage: is intended for ...

The firm has received reports of stent migration after implantation

FDAApr 12, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: VICI RDS VENOUS STENT System Product Usage: is indicated...

The firm has received reports of stent migration after implantation

FDAApr 12, 2021Nationwide• Boston Scientific Corporation

Cephalexin Oral Suspension (Preferred) – impurity issue (2021)

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Class IIModerate

FDAApr 12, 2021CA• Preferred Pharmaceuticals, Inc.

INNOVA MEDICAL GROUP, INC.: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 A...

Due to distributing test kits to customers who were not part of a clinical investigation.

FDAApr 9, 2021Nationwide• INNOVA MEDICAL GROUP, INC.

INNOVA MEDICAL GROUP, INC.: COVID-19 Self-Test Kit * INNOVA * 7T

Due to distributing test kits to customers who were not part of a clinical investigation.

FDAApr 9, 2021Nationwide• INNOVA MEDICAL GROUP, INC.

Flurandrenolide Ointment (Teligent) – specification failure (2021)

Failed Impurities/Degradation Specifications:

Class IIModerate

FDAApr 9, 2021Nationwide• Teligent Pharma, Inc.

Ginseng Power 5000 (NSNY) – undeclared ingredients (2021)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

FDAApr 8, 2021Nationwide• NSNY Distributor Inc

OrgaZEN 7000 (NSNY) – undeclared ingredients (2021)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil

FDAApr 8, 2021Nationwide• NSNY Distributor Inc

Roche Diagnostics Operations, Inc.: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Pr...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable cardiac resynchronization therapy pacemakers ...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Programmers - Product Usage: used to treat arrhythmias re...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01...

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable Pulse Generators - Product Usage: used to tre...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager - Product Usage: used t...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager (24970A). used to inte...

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

PremierZen Extreme 3000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

PremierZen Black 5000 (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

Triple SupremeZen Plus (Hyobin) – unapproved ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.

Class IIModerate

FDAApr 6, 2021Nationwide• Hyobin LLC

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