My HPRA: Register

Summary of Field Safety Notices - August 2017

Notice type: 3rd Party Publications

Date: 01/09/2017

  

Further Information:
Abbott  
ARCHITECT Free T4 Reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V31706


Abbott  (Saint Jude Medical)
Accent™/ Anthem™, Accent MRI™/ Accent ST™, Assurity™/ Allure™ and Assurity MRI™ devices
Advice regarding a software upgrade. HPRA Ref: V33048


Abbott Molecular Inc.
Abbott RealTime HIV-1 assay
Advice regarding a device removal. HPRA Ref: V32867


Alere
Alere HIV Combo
Advice regarding the use of the device. HPRA Ref: V32561


Baxter Healthcare Corporation
Artiset HD SN HC
Advice regarding the use of the device. HPRA Ref: V30162


Becton Dickinson
BD MultiTEST™ CD3/CD8/CD45/CD4
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32700


Becton Dickinson
BD MAX™ Vaginal Panel
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32614


Biomerieux
BacT/ALERT BPN Culture Bottle
Advice regarding a device modification. HPRA Ref: V32454


Biomerieux
VITEK® MS Instrument
Advice regarding the use of the device. HPRA Ref: V30973


Biomerieux
Mueller Hinton E Agar (MHE)
Advice regarding the use of the device. HPRA Ref: V32773


Biomerieux
VITEK® 2 Gram-Positive (GP) Identification (ID) Test Kit
Advice regarding a device removal. HPRA Ref: V33032


Boston Scientific Corporation
AngioJet® Ultra 5000A Console Foot Switch. FSN 1
AngioJet® Ultra 5000A Console Foot Switch. FSN 2
Advice regarding the use of the device. HPRA Ref: V30784


DePuy Synthes
Locking Compression Plate (LCP) Drill Sleeve
Advice regarding the use of the device. HPRA Ref: V32875


DePuy Synthes
Impactor for PFNA Blade
Advice regarding a device removal. HPRA Ref: V30236


Elekta / Nucletron BV
Oncentra Brachy 4.5
Advice regarding a software upgrade. HPRA Ref: V32874


Maquet Cardiopulmonary Gmbh
PLEGIOX Cardioplegic Heat Exchanger
Advice regarding the use of the device. HPRA Ref: V32784


Mercator MedSystems, Inc
Blowfish® Transbronchial Micro-Infusion Catheter
Advice regarding a device removal. HPRA Ref: V32902


Microline Surgical Inc.
ReNew Reusable Laparoscopic Instrument Tips
Advice regarding a device removal. HPRA Ref: V32810


Millipore (UK) Limited
BIOSCOT® Anti-Fyb Monoclonal Blood Grouping Reagent
Advice regarding a device removal. HPRA Ref: V32814


Oscor Europe GmbH
ATAR™ Extension Cables
Advice regarding a device removal. HPRA Ref: V32458


Philips GmbH
IntelliVue Multi Measurement Server/Server SLCP/Server X2 / IntelliVue Patient Monitor Models MP2/MP5
Advice regarding a software upgrade. HPRA Ref: V33016


Randox Laboratories
Liquid Cardiac Control - Level 3
Advice regarding a device removal. HPRA Ref: V32804


Randox Laboratories
Randox Acusera Premium and Premium Plus QC
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32822


Richard Wolf GmbH
ARTHROline Punch
Advice regarding a device removal. HPRA Ref: V32673


Roche
Mixed sample results in immunochemistry modules
Advice regarding a software upgrade. HPRA Ref: V32325


Roche
CFSN cobas 8000 core unit SBN-CPS-2017-017
Advice regarding a software upgrade. HPRA Ref: V32622


Sage Products LLC
Oral Care Products,Toothette, Q-Care
Advice regarding a device removal. HPRA Ref: V33024


Siemens Healthcare GmbH
Sensis Systems
Advice regarding a device modification. HPRA Ref: V31564

  
Smiths Medical ASD Inc
UniPerc® Adjustable Flange Tracheostomy Tube
Advice regarding a device removal. HPRA Ref: V32889


Spectranetics Corporation
Bridge Occlusion Balloon
Advice regarding the use of the device. HPRA Ref: V32993


Sysmex
Fluorocell PLT
Advice regarding a device removal. HPRA Ref: V33047


Terumo
FemoSeal™ Vascular Closure System
Advice regarding a device removal. HPRA Ref: V32936


ThermoFisher Scientific
Thermo Scientific™ Remel Streptex Rapid Latex Agglutination Test & Streptex Extraction Enzyme
Advice regarding a device removal. HPRA Ref: V32854


ThermoFisher Scientific
Thermo Scientific™ Remel™ Wellcolex™ Colour Shigella
Advice regarding a device removal. HPRA Ref: V32952


Vygon
Umbilical Catheter
Advice regarding a device removal. HPRA Ref: V32777

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