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 growt
Check against the official notice below — it lists the full affected range.
bioMerieux, Inc. is recalling 516 units of the BACT/ALERT VIRTUO system with Version R2.0 Firmware, an automated microbial detection system used for incubating samples. The issue affects all serial numbers with Reference Number 411660 and UDI 03573026369767. The firmware allows Field System Engineers to relocate four resident calibration standards from their designated locations in cells P24–P27 for servicing purposes. If these standards are not returned to their proper locations after service, the system may experience an anomaly.
The affected devices have been distributed worldwide, including throughout numerous U.S. states (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) and internationally to countries including Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, Colombia, Germany, Spain, France, the United Kingdom, Hong Kong, India, Italy, Japan, South Korea, the Netherlands, Portugal, Sweden, and Singapore, among others. The source record does not specify a remedy or what affected consumers should do.
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: 516 units Lot/code info: Reference Number 411660, UDI 03573026369767, all serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.