medical Class II Updated 2018-10-31

bioMerieux, Inc. recalls BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware

Recalled Product

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 growth from blood and other normally sterile body fluids.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Reference Number 411661, UDI 03573026369774, all serial numbers
View official government recall

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