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BACT/ALERT® 3D RIGHT INCUBATION MODULE

BIOMERIEUX , INC. · Model 210161 · UDI-DI 03573026049591

MDB Prescription
2
510(k) clearances
6,422
Adverse events (13 deaths)
76
Recalls
19
Facilities

Description

The BacT/ALERT 3D Right Incubator Module has four independent drawers of 60 cells each. Patented cell flags track bottle movements between cells for greater ease of use.

Recalls

DateFirmReason
2025-09-23Becton 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
2025-09-23Becton 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
2024-10-31Becton 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
2024-10-31Becton 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
2024-10-31Becton 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
2024-10-31Becton 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
2023-09-12Becton 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.
2018-06-27bioMerieux, 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
2018-06-27bioMerieux, 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
2018-06-27bioMerieux, 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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Data 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.