Alert

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Title	Hits
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.	Hits: 6766
December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.	Hits: 4698
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	Hits: 7475
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]	Hits: 4666
December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.	Hits: 9080
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	Hits: 9228
December 2021 : Corrective Action Notification FCO-02961-D : Single FOV Static PET reconstruction bug	Hits: 4615
December 2021 : Notification on Initial Report for CR-2021-IGT-PUN-011 (FCO71800101) - Zenition 70 Wireless Footswitch Safety Notification : Wireless footswitch connection issues causing interruption of live Fluoroscopy imaging or exposure	Hits: 4477
December 2021 : FSN : QIAcube Connect MDx Instrument REF 9003070 - issue with the text contained within several protocols which run on the QIAcube® Connect MDx instrument.	Hits: 12253
December 2021 : Field Safety Notice NC 3946 DEFIGARD Touch 7 (Initial Report) : Possible that a defibrillation shock cannot be delivered.	Hits: 5116