The following documents are summary of some medical device safety information related to potentially hazardous cases. It only serves as a quick reference and in no way should be considered as exhaustive and up-to-date. Please refer to the source of information and your product supplier for details.
Listing of Recalls
Listing of Field Safety Notice
- 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.
- December 2021 : FCA Notification 2021-003M _Olympus Evis Exera II Duodenovideoscope TJF-Q180V : Supplemental material for inspection.
- 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
- 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]
- December 2021 : FSN 0321 MCC/21/005/IU : Sevoflurane vaporizers for Flow Family Anesthesia systems - presence of a yellow substance in the vaporizer.