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October 2021 : Field Corrective Action Notification QC-11-02 - DR0704G Pathodxtra Strep Group D Latex FSN-2021-010 : Lots 3312966 & 3312967 are not performing to IFU criteria.
Dikunjungi: 2669
October 2021 : Urgent Field Safety Notice FSCA260 : BIPOLAR CUP TRIAL HEAD - Update reprocessing of the Bipolar Cup trial head
Dikunjungi: 8252
October 2021 : FSCA LASW 21-01 Aptio Automation : Interface Module to the ADVIA®Centaur XP/XPT
Dikunjungi: 11563
October 2021 : DELFIA® Xpress Free hCGß kit : Potential for decreased analyte measurement withDELFIA® Xpress Free hCGßkits
Dikunjungi: 7514
October 2021 : Abbott Assurity and Endurity pacemaker (our ref. FA-Q121-CRM-2) : For a subset of Assurity and Endurity Pacemakers
Dikunjungi: 4741
October 2021 : Field Safety Notice AX067/21/S : Missing regular reboot of the system may result in frozen vital signs
Dikunjungi: 7485
September 2021 : Urgent Product Correction FA29SEP2021 ARCHITECT ARCHITECT System software v9.45/9.50
Dikunjungi: 3169
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: 6012
September 2021 : 2021-IGT-PUN-010 (FCO72300030) - Firmware Upgrade for Intuis System
Dikunjungi: 3402
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: 9698
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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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