Recall Z-0228-2019

Reason for recall

The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.

FDA-determined cause: Software design

Action taken

bioMerieux were initially informing customers with on-site visits beginning on 06/27/2018. The letter informed customers of the anomaly and that local Field Service Engineers were confirming the calibration standards are in the designated bottle cell locations. Actions requested included to ensure the recall notice was distributed to applicable personnel within the organization, notify bioMerieux support if a patient/test bottle is loaded into cells P23-P27, print or view bottle reports to ensure accurate bottle results, store the recall letter with bioMerieux documentation, and complete and return the Acknowledgement Form. A second notification was initiated on about 08/08/2018. The letter was mailed via FedEx Overnight to ensure all customers were informed of the recall prior to the local Field Service Engineers performing their visit and device examination. Instructions included to ensure the recall notification was distributed to all appropriate personnel in the organization, to be vigilant when reviewing alarms for anonymous and/or duplicate bottles, if the customer becomes aware of the patient/test bottles located in cells P24-P27 to contact their local bioMerieux support, to view and/or print bottle reports to ensure accurate bottle results, to store the recall notification with bioMerieux, Inc. BACT/ALERT VIRTUO documentation, and to complete and return the Acknowledgement Form in Attachment A. Questions can be directed to loca bioMerieux, Inc. Clinical Custome Service representative at (800) 682-2666 or Industry Customer Service representative at (800) 634-7656.