bioMerieux, Inc. recalls BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection Sy…

Recall date

June 27, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0229-2019

FDA classification

Class II

Brand / firm

bioMerieux, Inc.

Sold / distributed

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 Ki…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.