BACT/ALERT VIRTUO system, A Unit China, 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
Check against the official notice below — it lists the full affected range.
bioMerieux, Inc. is recalling the BACT/ALERT VIRTUO system, a microbial detection instrument with Version R2.0 firmware. The recalled units have a firmware feature that allows Field System Engineers to relocate four resident calibration standards during servicing of cells P24-P27. If these calibration standards are not returned to their designated locations after servicing, the instrument may experience an anomaly in operation. Eight units were distributed worldwide across numerous U.S. states and multiple countries internationally, identified by Reference Number 419947 and UDI 03573026509538.
The recall affects all serial numbers of this model and lot. The source document does not specify a remedy or recommended action for consumers who have this equipment.
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: 8 units Lot/code info: Reference Number 419947, UDI 03573026509538, all serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.