Recall Z-0230-2019 ยท MDB System, Blood Culturing
bioMerieux, Inc.
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 growth from blood and other normally sterile body fluids.
| Date | Jun 27, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | bioMerieux were initially informing customers with on-site visits beginning on 06/27/2018. The letter informed customers of the anomaly and that local Field Service Engineers were confirming the calibration standards are in the designated bottle cell locations. Actions requested included to ensure the recall notice was distributed to applicable personnel within the organization, notify bioMerieux support if a patient/test bottle is loaded into cells P23-P27, print or view bottle reports to ensure accurate bottle results, store the recall letter with bioMerieux documentation, and complete and |
| Quantity | 8 units |
| 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, Unite |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.