Alert - Medical Device Authority (MDA)

List of articles in category Alerts
Tajuk	Dikunjungi
FIELD CORRECTIVE ACTION (FCA) LISTING FOR JUNE 2022	Dikunjungi: 2886
FIELD CORRECTIVE ACTION (FCA) LISTING FOR MAY 2022	Dikunjungi: 2889
FIELD CORRECTIVE ACTION (FCA) LISTING FOR APRIL 2022	Dikunjungi: 2414
FIELD CORRECTIVE ACTION (FCA) LISTING FOR MARCH 2022	Dikunjungi: 2380
December 2021 : Notification of Initiation of FSCA (MY-FSN-CPS-2020-091) - version 8 Elecsys CA 19-9 : Non-reproducible elevated results with certain reagent lots on cobas e 801.	Dikunjungi: 2746
December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.	Dikunjungi: 2807
December 2021 : Field Correction Action Report - DELFIA® Xpress_R2021004 : Potential for decreased analyte measurement with DELFIA® Xpress hAFP, Free hCGß, PAPP-A, and hCG kits	Dikunjungi: 4581
December 2021 : [TC2021-192] [Follow Up: Urgent Product Correction] [Availability of Application Software Version 5.13.4 Modification (MOD) 58 & 0.5M NaOH Usage Guidelines for ORTHO VISIONR and ORTHO VISIONR Max Analyzer]	Dikunjungi: 2600
December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.	Dikunjungi: 2785
December 2021 : Field Safety Notification FA-21073 on AU/DxC AU Uric Acid : Failed to meet the conjugated bilirubin interference specification for the serum application as defined in IFU	Dikunjungi: 2344

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