BACT/ALERT VIRTUO recallZ-0229-2019 · bioMerieux, Inc. · initiated Jun 27, 2018

Why it was recalled

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 root cause category: Software design

What the company is doing

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.

Recall details

Recall number

Z-0229-2019

Status

Terminated

Initiated by the company

Jun 27, 2018

Recalling firm

bioMerieux, Inc.

Quantity

151 units

Product code

MDB

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.

Product description

BACT/ALERT VIRTUO system, B 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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• BACT/ALERT® VIRTUO® 411661

  Biomerieux , Inc. · System, blood culturing
  1 recall4 reports

Product lines

• BACT/ALERT VIRTUOBiomerieux , Inc. · 2 models · 41 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 80759).

• Z-0228-2019 · Terminated
  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 incuba…