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Dimension Vista System - Ca15-3 Flex Reagent Cartridge
Siemens Healthineers has received customer complaints for negative patient bias with the Dimension Vista Loci Ca15-3 assay. Siemens has confirmed the Dimension Vista Loci Ca15-3 lots show a negative bias with patient samples. The mean patient sample bias…
RecallHealth product recall | 2022-07-25
Dimension Exl System - Cardiac Troponin-I (CTnI) Assay
Siemens Healthcare Diagnostics Inc. has confirmed that Dimension Cardiac Troponin I (lTni and CTnI) lots (ea2314 and ga2323) shows a positive bias with lithium heparin plasma samples from individuals that are expected to be below the 99th percentile of 0…
RecallHealth product recall | 2022-06-13
Siemens Healthcare Diagnostics Inc. has confirmed customer observations of falsely elevated results when using plasma specimens across the entire analytical measuring range (AMR) with the Atellica IM enhanced estradiol (EE2) assay. Results demonstrate…
RecallHealth product recall | 2022-03-14
Atellica Ch 930 Analyzer
Siemens Healthcare Diagnostics has identified issues with the Atellica CH 930 Analyzer, which are installed with Atellica solution software (SW) versions V1.25.1 and lower when using open channelassays. Siemens Healthineers assays are not impacted.…
RecallHealth product recall | 2021-12-07