A customer had reported a false positive oxa and kpc marker while utilizing verigene bc-gn assay.The customer had altered the therapy based on the verigne results, there was no adverse event or harm reported with this event.After further investigation of the event and product lot number, it was determined that the device had malfunctioned and provided false positive results due to non-specific binding.This was previously identified as a malfunction that was communicated to customers through a customer advisory notice (can) per recall 3006028115-10/9/2020-001-c (submitted to fda on 09 october 2020).At the time of the event, it was identified that the customer had not yet installed the latest software per the can instruction.The customer's software was updated on 19 november 2020 to mitigate any further issues.There was no patient injury or death identified as part of this event.In a case where updated information becomes available a follow-up report will be submitted.
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