Health product recall

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

Starting date:
October 21, 2019
Posting date:
November 1, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-71477

Last updated: 2019-11-01

Affected Products

  1. BACT/ALERT VIRTUO - A UNIT
  2. BACT/ALERT VIRTUO - B UNIT

Reason

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.

Affected products

A. BACT/ALERT VIRTUO - A UNIT

Lot or serial number

All lots.

Model or catalog number

411660

Companies
Manufacturer
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES

B. BACT/ALERT VIRTUO - B UNIT

Lot or serial number

All lots.

Model or catalog number

411661

Companies
Manufacturer
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES