A customer had reported a false negative ctx-m marker while utilizing verigene bc-gn assay, a change in therapy resulted based on the verigene results.No patient harm based on the change in therapy was reported.The verigene bc-gn consumable was not available.Verigene reader and processor used with the consumable, were evaluated on 05 nov 2020 for a malfunction, there was no indication of a device malfunction.This investigation is ongoing, if additional information becomes available a follow-up report will be submitted.
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