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October 2021 : Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Dikunjungi: 5013
October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Dikunjungi: 7901
September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50
Dikunjungi: 3436
September 2021 : FSCA LASW 21-02 Aptio by Inpeco and FlexLab Automation : Aptio Automation Firmware (FW) for the ADVIA Centaur XP/XPT Interface Module may lead, in specific and rare cases, to an incorrect association of test result(s) to sample ID.
Dikunjungi: 6453
September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System
Dikunjungi: 3673
September 2021 : FSCA ACHC 21-14 ADVIA and Atellica UCFP carryover : Falsely Depressed Enzymatic Hemoglobin A1c Results due to Reagent Carryover from the Urinary/Cerebrospinal Fluid Protein (UCFP) Assay.
Dikunjungi: 10136
September 2021 : Field-Corrective Action Notification 20001103083 : Digital Linear Accelerator - For service user: precautions to be taken when handling diode D1
Dikunjungi: 4344
September 2021 : Corrective action reporting for FMI 32081 : Mounting issue for LullabyTMResus Plus/Prime dovetailmounts ontoLullabyTMWarmer side rails
Dikunjungi: 3339
September 2021 : Product Field Corrective Action PR 2795031 - Stryker NAV3/NAV3i Platforms : Microsoft Windows Print Spooler Vulnerabilities
Dikunjungi: 3255
September 2021 : Notification of Initiation of FSCA (MY-FSN-RDS-Molecular Lab-2021-011) - cobas® EGFR Mutation Test v2: Potential for False Mutation Detected results for exon20 Insertion.
Dikunjungi: 8909
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Home
Pengenalan
Latar Belakang
Visi, Misi & Nilai Teras
Objektif
Hubungi Kami
Carta Organisasi
Code of Ethics and Conduct
Board of Directors
Top Management
Bahagian
Pejabat Ketua Eksekutif
Unit Komunikasi Korporat
Unit Undang-undang
Unit Integriti
Secretarial Unit
Bahagian Pendaftaran, Pelesenan Dan Penguatkuasaan
Post Market & Enforcement Division
Policy & Strategic Planning Division
International and Industry Affairs Division
Unit Pengurusan Dan Perkhidmatan
Soalan Lazim
Single License Policy Implementation
Pendaftaran, Pelesenan & Penguatkuasaan
Labelling of Medical Devices
Technical Evaluation
Hubungi
Borang Aduan Pelanggan
Kajian Kepuasan Pelanggan
Direktori Kakitangan
Dokumen
Perundangan
Surat Pekeliling
Dokumen Panduan
Garis panduan
Standard
General Directions
Strategic Plan
Persembahan Slide
Infographic
Organizational Anti Corruption Plan (OACP) MDA 2022 - 2026
Buletin MDA
Press Release
Media Coverage (Newspaper Cutting)
Customer Satisfaction Survey Result
Laporan Tahunan
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