Home / Recalls / bioMerieux, Inc. / Z-0230-2019

Z-0230-2019 Class II Terminated

Recalled by bioMerieux, Inc. — Durham, NC

FDA device recall Z-0230-2019 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: 8 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: 8 units

Product Description

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.

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 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

Reference Number 419947, UDI 03573026509538, all serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0230-2019
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by bioMerieux, Inc.

Z-3231-2026 Class II — VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED… (Jul 24, 2026)
Z-2715-2026 Class II — VITEK 2 AST-N447 TEST KIT Product reference 424620 (Jun 4, 2026)
Z-1236-2026 Class II — VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n)… (Jan 5, 2026)
Z-2671-2025 Class II — VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation… (Jun 26, 2025)
Z-1464-2024 Class I — VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial… (Mar 14, 2024)
Z-1201-2023 Class II — MYLA comprises AST Filters in conjunction with VITEK MS; middleware which… (Feb 6, 2023)
Z-0786-2023 Class II — API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 (Nov 9, 2022)
Z-0841-2023 Class II — ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 (Nov 9, 2022)
Z-0827-2023 Class II — ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 (Nov 9, 2022)
Z-0840-2023 Class II — GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 (Nov 9, 2022)