Product Wiki · Recalls · Health Canada — Medical Devices

BACT/ALERT VIRTUO - A & B UNIT (2019-10-21) — recall 59936

Health Canada — Medical Devices · Canada · 2019-11-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59936
Date of alert
2019-11-01
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: A problem was reported by a customer where, on a BACT/ALERT VIRTUO R2.0 with MYLA, patient culture bottles of various types were "discharged at 7 days instead of 10 days". The customer reported that the maximum test time (MTT) of each bottle was modified at the LIS from seven (7) days to ten (10) days; however, the instrument only tested the bottles for seven days and then discarded them to the waste bin. The Biomerieux investigation could not duplicate the described behavior. However, evaluation concluded the root cause to be a VIRTUO software/firmware timing anomaly whereby the processing of multiple software actions, following a new bottle scan, within a one (1) second time interval may lead to a MTT discrepancy.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bactalert-virtuo-b-unit-2019-1

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