bioMerieux, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0228-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: June 27, 2018

Date Posted: October 31, 2018

Recall Number: Z-0228-2019

Event ID: 80759

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.

Status: Terminated

Product Quantity: 516 units

Code Information:

Reference Number 411660, UDI 03573026369767, all serial numbers

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated