Device recall: BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection Sys

FDA enforcement event 80759 · Class II · initiated 27 Jun 2018 · status Terminated · terminated 21 Jul 2020

DeviceVoluntary: Firm initiated3 product recordsDurham, NC

bioMerieux, Inc. (Durham, NC) initiated this device recall on 27 Jun 2018; FDA lists 3 product records under event 80759, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 21 Jul 2020. Initiation: voluntary: firm initiated. bioMerieux, Inc. has 57 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

bioMerieux, Inc., Durham, NC.

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

"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…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0228-2019	BACT/ALERT VIRTUO system, A 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…	516 units	Class II	Terminated	31 Oct 2018
Z-0229-2019	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…	151 units	Class II	Terminated	31 Oct 2018
Z-0230-2019	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…	8 units	Class II	Terminated	31 Oct 2018

Context

92%of 2018 device events are Class II1,074 events that year

3product records in this eventfirm median: 1

57events on this register for the firm

Other enforcement events for bioMerieux, Inc.

Initiated	Product (first record)	Type	Class	Records
4 Jun 2026	VITEK 2 AST-N447 TEST KIT Product reference 424620	Device	Class II	1
5 Jan 2026	VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem	Device	Class II	1
26 Jun 2025	VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system cons	Device	Class II	1
14 Mar 2024	VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) A	Device	Class I	1
6 Feb 2023	MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments f	Device	Class II	1
9 Nov 2022	API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300	Device	Class II	94
20 Jul 2022	NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.	Device	Class II	1
13 Jul 2022	VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8	Device	Class II	1
29 Mar 2022	VITEK 2 Systems and VITEK 2 with MYLA.	Device	Class II	1
9 Feb 2022	VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.	Device	Class II	1

All 57 events for bioMerieux, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "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…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Jul 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.