Siemens healthcare diagnostics inc.Has investigated the event of a negative bias with the dimension vista loci ca 15-3 assay on the dimension vista system.Siemens has confirmed the dimension vista loci ca 15-3 assay showed a negative bias with patient samples.Siemens issued an urgent medical device correction, vc-22-02.A.Us dated (b)(6) 2022 and an urgent field safety notice vc-22-02.A.Ous dated (b)(6) 2022 to all dimension vista loci ca 15-3 customers.The letters instructed customers to use lot specific correlation factors provided for the affected lots.Siemens healthineers is working to restore assay performance and until such time, subsequent lots of dimension vista loci ca 15-3 may contain an alert card within the carton listing lot specific correlation factors.
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