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 growt
Check against the official notice below — it lists the full affected range.
The BACT/ALERT VIRTUO Microbial Detection System with Version R2.0 Firmware is subject to recall. The system's firmware allows field service engineers to relocate four resident calibration standards from their designated locations (cells P24-P27) to service those cells. If these calibration standards are not returned to their proper positions after servicing, the system may experience an anomaly. A total of 151 units have been affected by this issue.
The recalled systems were distributed worldwide, including across numerous U.S. states (from Arkansas to Wyoming) and internationally to countries including Canada, Australia, Japan, the United Kingdom, Germany, France, and others. The recall affects all serial numbers of devices with Reference Number 411661 and UDI 03573026369774. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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, Thailan Quantity: 151 units Lot/code info: Reference Number 411661, UDI 03573026369774, all serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.