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Urgent Field Safety Notice for Zirkon Primer by GDF Gesellschaft für Dentale Forschung und Innovationen GmbH PDF, 119KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group Dental products - dental material
Reference 01776/19

Urgent Field Safety Notice for cobas p 612 pre-analytical system by Roche Diagnostics GmbH PDF, 385KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07836/18

Urgent Field Safety Notice for NEOselect, NEOonsite - Data Analysis & NEOdb by NEO New Oncology GmbH PDF, 107KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 01462/19

Urgent Field Safety Notice for Xpert GBS by Cepheid PDF, 1MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00963/19

Urgent Field Safety Notice for Mentype MycoDermQS Lateral Flow by Biotype Diagnostic GmbH PDF, 210KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 01636/19

Urgent Field Safety Notice for DiaSpect Hemoglobin T-LOW by DiaSpect Medical GmbH PDF, 3MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01538/19

Urgent Field Safety Notice for B·R·A·H·M·S uE3 KRYPTOR by Brahms GmbH, part of Thermofisher Scientific PDF, 2MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01381/19

Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG PDF, 359KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01563/19

Urgent Field Safety Notice for ARCHITECT Estradiol Reagent, Alinity i Estradiol Reagent Kit by Abbott Ireland Diagnostics Division PDF, 123KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01341/19

Urgent Field Safety Notice for Enzygnost Syphilis by Siemens Healthcare Diagnostics Products GmbH PDF, 910KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 01058/19

Urgent Field Safety Notice for DHEA ELISA by IBL International GmbH PDF, 151KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01600/19

Urgent Field Safety Notice for Specific IgG4 ELISA by Dr. Fooke-Achterrath Laboratorien GmbH PDF, 130KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01383/19

Urgent Field Safety Notice for ADVIA Chemistry XPT System by Siemens Healthcare Diagnostics Inc. Tarrytown PDF, 58KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02042/19

Urgent Field Safety Notice for IDS-iSYS ACTH by Immunodiagnostic Systems Ltd PDF, 660KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00907/19

Urgent Field Safety Notice for Calcium CA3871 by Randox Laboratories Ltd PDF, 1MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01420/19

Urgent Field Safety Notice for Stratec GEMINI und Stratec GEMINI Combo by STRATEC SE PDF, 2MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01233/19

Urgent Field Safety Notice for STA - VWF:RCo by Stago PDF, 151KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01019/19

Urgent Field Safety Notice for t-PSA Rapid Test / Free PSA Rapid Test by Dongguan Bosh Biotechnologies, Ltd. PDF, 4MB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 02020/19

Urgent Field Safety Notice for BD MAX Enteric Bacterial Panel by GeneOhm Sciences Canada, Inc. PDF, 209KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 01735/19

Urgent Field Safety Notice for Alaris VP with Guardrails by CareFusion Switzerland 317 Sarl PDF, 90KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01842/19

Urgent Field Safety Notice for UniMatch Plus Software by One Lambda Inc. PDF, 126KB, File does not meet accessibility standards Date: 21. February 2019 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 01314/19

Urgent Field Safety Notice for SMF Stem With Stiktite by Smith & Nephew, Inc., PDF, 79KB, File does not meet accessibility standards Date: 20. February 2019 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01904/19

Urgent Field Safety Notice for WDC Detachement Controller by SEQUENT MEDICAL Inc. PDF, 2MB, File does not meet accessibility standards Date: 20. February 2019 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01967/19

Urgent Field Safety Notice for Septiflow Circuit by Altera Tibbi Maiz.San.ve Tic.A.S Turan Mah. PDF, 1MB, File does not meet accessibility standards Date: 20. February 2019 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 01949/19

Urgent Field Safety Notice for Carescape One by GE Medical Systems Information Technologies, Inc. PDF, 146KB, File does not meet accessibility standards Date: 20. February 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 01924/19

Urgent Field Safety Notice for COBRA Fusion 150 Minimally Invasive Ablation System by AtriCure, Inc. PDF, 804KB, File does not meet accessibility standards Date: 19. February 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00979/19

Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc. PDF, 126KB, File does not meet accessibility standards Date: 19. February 2019 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01201/19

Urgent Field Safety Notice for EMS-Stretcher by Bucher Leichtbau AG PDF, 1MB, File does not meet accessibility standards Date: 15. February 2019 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 01699/19

Urgent Field Safety Notice for Interactive Precision IO Scan Adapter by Implant Direct Sybron Manufacturing, LLC. PDF, 401KB, File does not meet accessibility standards Date: 15. February 2019 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 14919/18

Urgent Field Safety Notice for UROSKOP OMNIA and UROSKOP OMNIA MAX by Siemens Healthcare GmbH, X-Ray Products (XP) PDF, 4MB, File does not meet accessibility standards Date: 15. February 2019 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for urological diagnostics
Reference 01581/19