Siemens—ADVIA Centaur Rubella IgG (RUBG) and Rubella IgM (RUBM) Reagents Used with ADVIA Centaur XP Systems: Assigned Value Card (AVC) May Be Unable to Save Because of a Space in the Calibrator Name
July 15, 2020 | Risk Management News
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In a June 2020 Urgent Field Safety Notice letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and the German Federal Institute for Drugs and Medical Devices (BfArM), Siemens states that calibrator value information for the above reagents may not be saved when calibrator assigned value cards are scanned or manually entered onto the ADVIA Centaur XP systems. This problem prevents the assays from being tested, potentially...