Culture Media, General Nutrient Broth
Microbiology · 21 CFR 866.2350
Recent MDR events
78 adverse event reports on file
- BD BBL¿ BRAIN HEART INFUSIONAug 29, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04314
- BD BBL¿ BRAIN HEART INFUSION BROTHAug 27, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04458
- BD BBL¿ BRAIN HEART INFUSION BROTHAug 27, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04457
- BD BBL¿ BRAIN HEART INFUSION BROTHAug 27, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04437
- BD BBL¿ BRAIN HEART INFUSIONAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04356
- BD BBL¿ BRAIN HEART INFUSIONAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04358
- BD BBL¿ BRAIN HEART INFUSIONAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04355
- BD BBL¿ BRAIN HEART INFUSIONAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04357
- BD BBL¿ BRAIN HEART INFUSIONAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04354
- BD BBL¿ BRAIN HEART INFUSION BROTHAug 26, 2025MalfunctionBecton, Dickinson & Co. (sparks)1119779-2025-04375
Event type breakdown
Recalls
5 recall events for this product code
- Hardy DiagnosticsTerminatedDec 23, 2015
FB Broth, 10ml
The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
Z-0470-2016 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJan 25, 2013
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA***
Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
Z-0739-2013 · View FDA record ↗ - Becton Dickinson & Co.TerminatedMar 23, 2012
Fildes Enrichment, BBL brand, catalog #211866, in 5 ml tubes,10 tubes/package, manufactured by BD Diagnostic Systems, 250 Schilling Circle, Cockeysville, MD 210
In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
Z-1282-2012 · View FDA record ↗ - Remel, IncTerminatedMar 9, 2010
Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.
Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
Z-0979-2010 · View FDA record ↗ - bioMerieux, Inc.TerminatedUnknown
API 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
Z-0243-2022 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Chromagar
Saint-Denis Seine-Saint-Denis, FR
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Becton, Dickinson & Co.
SPARKS, MD, US
Hardy Diagnostics
Orcutt, CA, US
Anaerobe Systems
MORGAN HILL, CA, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Jiaoyue Pharmaceutical (huizhou) Co.ltd
Huizhou Guangdong, CN
Biomerieux Sa
LA BALME LES GROTTES Isere, FR
Legacy Biologicals
Baltimore, MD, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Hardy Diagnostics
Springboro, OH, US
Key Scientific Products
Stamford, TX, US
Becton, Dickinson & Co.
Cockeysville, MD, US
Analytichem Usa, Inc.
Winslow, ME, US
Remel, Inc.
LENEXA, KS, US
510(k) clearances
52 clearances for this product code
- American Sterilizer Co.Mar 5, 1985
K850143 · SPORDEX CULTURE MEDIA
- Anarobe SystemsAug 3, 1984
K842852 · BRAIN HEART INFUSION BROTH
- Anarobe SystemsAug 3, 1984
K842849 · TRYPTICASE SOY BROTH
- Anaerobe SystemsApr 4, 1984
K841221 · BRAIN HEART INFUSION BROTH
- Anaerobe SystemsApr 4, 1984
K841219 · SHOPPED MEAT CARBOHYDRATE
- Acumedia Manufacturers, Inc.Nov 7, 1983
K833300 · SABOURAUD BHI AGAR
- Carroll Biological Corp.Sep 12, 1983
K832620 · TRYPTIC SOY BROTH MEDIA
- Acumedia Manufacturers, Inc.Sep 12, 1983
K832569 · INFUSION BROTH