System, Blood Culturing
FDA product code MDB · Class I (low risk) · 21 CFR 866.2560 · Microbiology
68510(k) clearances
0PMA approvals
69recalls
Manufacturers
- Organon Teknika Corp. 19
- Biomerieux Inc 12
- Becton Dickinson Diagnostic Instrument Systems 8
- Bd Becton Dickinson Vacutainer Systems Preanalytic 7
- Becton, Dickinson and Company 7
- Becton Dickinson & Co. 4
- Difco Laboratories, Inc. 3
- Becton Dickinson Microbiology Systems 3
- Marion Laboratories, Inc. 1
- Oxoid U.S.A., Inc. 1
- Accumed Intl., Inc. 1
- Trek Diagnostic Systems, Inc. 1
- Bd Diagnostic Systems 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260213 | BD BACTEC FXI Culture SystemMDB · Traditional | BD Diagnostic Systems | 05/28/2026SE |
| K222591 | BD BACTEC Plus Aerobic/F Culture VialsMDB · Special | Becton, Dickinson and Company | 03/24/2023SE |
| K222559 | BD BACTEC Myco/F Lytic Culture VialsMDB · Traditional | Becton, Dickinson and Company | 03/24/2023SE |
| K190405 | BACT/ALERT MP Reagent SystemMDB · Traditional | bioMerieux, Inc. | 05/15/2019SE |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF PlusMDB · Traditional | bioMerieux, Inc. | 02/11/2019SE |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic…MDB · Traditional | Becton, Dickinson and Company | 03/16/2018SE |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMDB · Traditional | bioMerieux, Inc. | 03/28/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | Becton Dickinson | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | Becton Dickinson | 08/08/2016SE |
| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson and Company | 02/25/2016SE |
| K141810 | BD Bactec Plus Anaerobic/F (Plastic)MDB · Traditional | Becton, Dickinson and Company | 12/10/2014SE |
| K123903 | BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson & CO | 05/13/2013SE |
| K121455 | Bact/Alert FN Plus Culture BottleMDB · Traditional | bioMerieux, Inc. | 01/25/2013SE |
| K121446 | Bact/Alert PF Plus Culture BottleMDB · Traditional | bioMerieux, Inc. | 01/25/2013SE |
| K121461 | Bact/Alert Fa Plus Culture BottleMDB · Traditional | bioMerieux, Inc. | 01/22/2013SE |
| K120994 | BD BACTEC Plus PRIME Aerobic/F Culture VialsMDB · Traditional | Becton, Dickinson and Company | 08/07/2012SE |
| K113558 | BD BACTEC Plus Aerobic/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson and Company | 03/16/2012SE |
| K083572 | BD BACTEC Plus Aerobic/F Culture VialsMDB · Special | Becton, Dickinson & CO | 12/24/2008SE |
| K032306 | VersatrekMDB · Special | Trek Diagnostic Systems, Inc. | 08/22/2003SE |
| K031737 | Bact/Alert MP Culture Bottles (Plastic)MDB · Traditional | bioMerieux, Inc. | 07/14/2003SE |
| K021123 | Bact/Alert SN Culture BottleMDB · Traditional | bioMerieux, Inc. | 04/26/2002SE |
| K020931 | Bact/Alert SA Culture BottleMDB · Traditional | bioMerieux, Inc. | 04/18/2002SE |
| K020923 | Bact/Alert PF Culture BottleMDB · Traditional | bioMerieux, Inc. | 04/18/2002SE |
| K020815 | Bact/Alert FN Culture BottleMDB · Traditional | bioMerieux, Inc. | 04/18/2002SE |
| K020813 | Bact/Alert Fa Culture BottleMDB · Traditional | bioMerieux, Inc. | 04/17/2002SE |
| K000378 | Bact/Alert MB Culture BottleMDB · Traditional | Organon Teknika Corp. | 03/02/2000SE |
| K994343 | Bact/Alert SVMDB · Traditional | Organon Teknika Corp. | 02/10/2000SE |
| K993423 | Bact/Alert SAMDB · Traditional | Organon Teknika Corp. | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | Organon Teknika Corp. | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | Organon Teknika Corp. | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | Organon Teknika Corp. | 09/24/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | Organon Teknika Corp. | 09/03/1999SE |
| K992400 | Bactalert FaMDB · Traditional | Organon Teknika Corp. | 09/03/1999SE |
| K983772 | Mb/Bact Blood Culture BottleMDB · Traditional | Organon Teknika Corp. | 01/13/1999SE |
| K982263 | Mb/Bact Blood Culture BottleMDB · Traditional | Organon Teknika Corp. | 08/18/1998SE |
| K981736 | Bact/Alert 3D Microbial Detection SystemMDB · Traditional | Organon Teknika Corp. | 07/24/1998SE |
| K974883 | Bactec Mgit 960 SystemMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/01/1998SE |
| K970333 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | Becton Dickinson Microbiology Systems | 01/28/1998SE |
| K970512 | Bactec Myco/F Lytic Culture VialsMDB · Traditional | Becton Dickinson Microbiology Systems | 01/08/1998SE |
| K973325 | Bact/Alert Fan Culture BottlesMDB · Traditional | Organon Teknika Corp. | 12/02/1997SE |
| K973305 | Bact/Alert Culture BottlesMDB · Traditional | Organon Teknika Corp. | 11/17/1997SE |
| K972758 | Bactec Myco/F-Sputa Culture VialsMDB · Traditional | Becton Dickinson Microbiology Systems | 08/08/1997SE |
| K972756 | Modification of Est Culture System II - MycoMDB · Traditional | Accumed Intl., Inc. | 08/01/1997SE |
| K954932 | BBL Mgit ProductsMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 08/21/1996SE |
| K962210 | Bactec 9050 SystemMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 08/08/1996SE |
| K954468 | Mb/Bact Mycrobacteria Detection SystemMDB · Traditional | Organon Teknika Corp. | 07/22/1996SE |
| K946268 | Bactec(R) 9000TB SystemMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 05/21/1996SE |
| K954930 | Bactec Culture Vials, Lytic, AnaerobicMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 02/16/1996SE |
| K954927 | Bactec Peds Plus/F Culture VialsMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 02/16/1996SE |
| K954925 | Bactec LYTIC/10 Anaerobic/F Culture VialsMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 02/16/1996SE |
| K954921 | Bactec STANDARD/10 Aerobic/F Culture VialsMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 02/16/1996SE |
| K954924 | Bactec Peds Plus Cluture VialsMDB · Traditional | Becton Dickinson Diagnostic Instrument Systems | 02/08/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | Difco Laboratories, Inc. | 12/26/1995SE |
| K944594 | Bact/Alert Fan Culture BottleMDB · Traditional | Organon Teknika Corp. | 02/17/1995SE |
| K935711 | Bact/Alert Fan Aerobic Culture BottleMDB · Traditional | Organon Teknika Corp. | 08/30/1994SE |
| K934593 | Bact/Alert 120MDB · Traditional | Organon Teknika Corp. | 02/09/1994SE |
| K926304 | Bactec Peds Plus/FMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/04/1993SE |
| K925693 | Ez ViewMDB · Traditional | Difco Laboratories, Inc. | 01/15/1993SE |
| K921637 | Esp Blood Culture SystemMDB · Traditional | Difco Laboratories, Inc. | 07/14/1992SE |
| K922475 | Bactec 9120 SystemMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/01/1992SE |
| K920249 | Bact/Alert Pedi-BactMDB · Traditional | Organon Teknika Corp. | 04/23/1992SE |
| K921133 | Bactec Plus Aerobic/F and Anaerobic/F MediaMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/22/1992SE |
| K915796 | Bactec 9240 SystemMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/22/1992SE |
| K920933 | Bactec Fos Culture SupplementMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/17/1992SE |
| K903505 | Bact/Alert (TM)MDB · Traditional | Organon Teknika Corp. | 03/12/1991SE |
| K833888 | PenaseMDB · Traditional | Oxoid U.S.A., Inc. | 01/03/1984SE |
| K812315 | Bactec Resin Culture Med. 16AMDB · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/10/1981SE |
| K810613 | Antimicrobial Removal DeviceMDB · Traditional | Marion Laboratories, Inc. | 04/03/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0237-2026 Class II | BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog…Product service credentials used by some BD technical support teams to access certain BD products were… | Becton Dickinson & Co. | 09/23/2025Open, Classified |
| Z-0236-2026 Class II | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument…Product service credentials used by some BD technical support teams to access certain BD products were… | Becton Dickinson & Co. | 09/23/2025Open, Classified |
| Z-0596-2025 Class II | BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-0595-2025 Class II | BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-0594-2025 Class II | BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-0593-2025 Class II | BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385BD confirmed that product service credentials used by some BD technical support teams to access certain BD… | Becton Dickinson & Co. | 10/31/2024Open, Classified |
| Z-0110-2024 Class II | BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode… | Becton Dickinson & Co. | 09/12/2023Open, Classified |
| Z-0230-2019 Class II | BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The…The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident… | bioMerieux, Inc. | 06/27/2018Terminated |
| Z-0229-2019 Class II | BACT/ALERT VIRTUO system, B Unit, with Version R2.0 Firmware Product Usage: The…The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident… | bioMerieux, Inc. | 06/27/2018Terminated |
| Z-0228-2019 Class II | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The…The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident… | bioMerieux, Inc. | 06/27/2018Terminated |
| Z-0750-2016 Class II | BacT/ALERT FA, bioMrieux, Inc., Product Usage: BacT/ALERT Culture Bottles are used with…Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and… | bioMerieux, Inc. | 12/24/2015Terminated |
| Z-0749-2016 Class II | BacT/ALERT SN, bioMrieux, Inc. Product Usage: BacT/ALERT Culture Bottles are used with…Bottles may have been exposed to non-normal shipping conditions which may lead to media degradation and… | bioMerieux, Inc. | 12/24/2015Terminated |
| Z-1842-2015 Class II | VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK…Use of the recalled product may result in false positive reports. | Remel Inc | 05/19/2015Terminated |
| Z-1841-2015 Class II | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK…Use of the recalled product may result in false positive reports. | Remel Inc | 05/19/2015Terminated |
| Z-2057-2014 Class II | Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50…Bottles did not provide positive signals within the time frame of the quality control specification for one… | Remel Inc | 06/11/2014Terminated |
| Z-0870-2014 Class II | BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic…Improperly functioning component of a diagnostic medical device may cause false negative results in clinical… | Becton Dickinson & Co. | 12/09/2013Terminated |
| Z-0869-2014 Class II | BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument…Improperly functioning component of a diagnostic medical device may cause false negative results in clinical… | Becton Dickinson & Co. | 12/09/2013Terminated |
| Z-0028-2014 Class II | BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct…An in-vitro diagnostic reagent may be labeled with an incorrect barcode, which when scanned on associated… | Becton Dickinson & Co. | 09/09/2013Terminated |
| Z-0738-2013 Class II | BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be…BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. | bioMerieux, Inc. | 12/25/2012Terminated |
| Z-0329-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0328-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0327-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0326-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0325-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0324-2013 Class II | bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0323-2013 Class II | bioMerieux Kit, Instrument & Update, B.40 Dualt-ML, Industry instrument software update…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0322-2013 Class II | bioMerieux Kit, Instrument & Update, 3D IND USB-ML 02, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0321-2013 Class II | bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0320-2013 Class II | bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0319-2013 Class II | bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0318-2013 Class II | bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0317-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0316-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML05, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0315-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0314-2013 Class II | bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0313-2013 Class II | bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0312-2013 Class II | bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0311-2013 Class II | bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0310-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0309-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0308-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0307-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0306-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML04, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0305-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0304-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0303-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML 02, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0302-2013 Class II | bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML01, Clinical instrument software…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0301-2013 Class II | bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0300-2013 Class II | bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |
| Z-0299-2013 Class II | bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The…The product may mislabel patient information on culture specimen bottles due to a software miscommunication. | Biomerieux Inc | 10/16/2012Terminated |