Class 2 Device Recall BACT/ALERT VIRTUO

• Date Initiated by Firm: June 27, 2018
• Create Date: October 24, 2018
• Recall Status: Terminated on July 21, 2020
• Recall Number: Z-0228-2019
• Recall Event ID: 80759
• Product Classification: System, blood culturing - Product Code MDB
• Product: BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.
• Code Information: Reference Number 411660, UDI 03573026369767, all serial numbers
• FEI Number: 3002769706
• Recalling Firm/ Manufacturer: bioMerieux, Inc.; 100 Rodolphe St; Durham NC 27712-9402
• For Additional Information Contact: 800-682-2666
• Manufacturer 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: 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.
• Quantity in Commerce: 516 units
• Distribution: Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KS, LA, MI, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VT, WV. Distributed internationally to Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Germany, Spain, France, United Kingdom, Hong Kong, India, Italy, Japan, South Korea, Netherlands, Portugal, Sweden, Singapore, Thailand, South Africa, Saudi Arabia, Philippines, Myanmar, Serbia, Lebanon, United Arab Emirates, Slovenia, Qatar, Costa Rica, Croatia, Panama, Estonia, Israel, Philippines, Malaysia, Brunei Darussalam, Vietnam, Kuwait.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.