Z-0228-2019Class II

BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware

Name: Z-0228-2019 BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware
Creator: bioMerieux, Inc.
Published: 2018-06-27
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-06-27 / Terminated / root cause: software

FDA source

bioMerieux, Inc. began a recall of 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... on 2018-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0228-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-27
Posted: 2018-10-24
Terminated: 2020-07-21
Recalling firm: bioMerieux, Inc.
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.
Product code: MDB System, Blood Culturing
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.
Root cause tag: software
FDA root 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.
Product codes and lots: Reference Number 411660, UDI 03573026369767, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0228-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0228-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0229-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23
Z-0230-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-31	2018-10-23

Product code MDB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)