Z-0228-2019 Class II Terminated
FDA device recall Z-0228-2019 was initiated by bioMerieux, Inc. on Jun 27, 2018 and is designated Class II. 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… The recall status is terminated (terminated Jul 21, 2020). Affected quantity: 516 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 31, 2018
- Initiation Date
- Jun 27, 2018
- Termination Date
- Jul 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 516 units
Product Description
Reason for Recall
Distribution Pattern
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, Thailand, South Africa, Saudi Arabia, Philippines, Myanmar, Serbia, Lebanon, United Arab Emirates, Slovenia, Qatar, Costa Rica, Croatia, Panama, Estonia, Israel, Philippines, Malaysia, Brunei Darussalam, Vietnam, Kuwait.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0228-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026