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BACT/ALERT® 3D CONTROL MODULE
BIOMERIEUX , INC. · Model 210147 · UDI-DI 03573026049522
MDB
Prescription
2
510(k) clearances
6,448
Adverse events (13 deaths)
76
Recalls
19
Facilities
Description
The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one integrated touchscreen computer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2023-09-12 | Becton Dickinson & Co. | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial. |
| 2018-06-27 | bioMerieux, Inc. | 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 associa |
| 2018-06-27 | bioMerieux, Inc. | 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 associa |
| 2018-06-27 | bioMerieux, Inc. | 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 associa |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.