Culture Media, Selective Broth
Microbiology · 21 CFR 866.2360
Recent MDR events
34 adverse event reports on file
- TODD HEWITT BROTH + ANTIBIOTICS (TODD H-T)Apr 4, 2023MalfunctionBiomérieux, Sa9615755-2023-00001
- BD BBL¿ LIM BROTHJun 17, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-00915
- BD BBL¿ TRYPTICASE¿ SOY AGAR, HEAVY FILL STERILEFeb 16, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-00245
- BD RODAC¿ SNAP LID TRYPTICASE¿ SOY AGAR (TSA) WITH LECITHIN & POLYSORBATEJan 26, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-00124
- BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) WITH LECITHIN & POLYSORBATEFeb 8, 2021MalfunctionBecton, Dickinson & Co. (sparks)1119779-2021-00266
- *Jan 31, 2012MalfunctionBecton Dickinson2441080
- MICROSCAN PROMPT INOCULATION SYSTEM-DOct 9, 2006MalfunctionDade Behring, Inc.2919016-2006-00037
- MICROSCAN PROMPT INOCULATION SYSTEM-DOct 9, 2006MalfunctionDade Behring, Inc.2919016-2006-00040
- MICROSCAN PROMPT INOCULATION SYSTEM-DOct 9, 2006MalfunctionDade Behring, Inc.2919016-2006-00038
- MICROSCAN PROMPT INOCULATION SYSTEM-DOct 9, 2006MalfunctionDade Behring, Inc.2919016-2006-00035
Event type breakdown
Recalls
2 recall events for this product code
- Remel, IncOpen, ClassifiedSep 8, 2023
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Z-2531-2023 · View FDA record ↗ - Becton Dickinson & Co.TerminatedOct 15, 2003
BBL (TM) LIM Broth, in glass slant tubes and packaged 100 tubes per carton, catalog #296266.
Broth for growing selective bacteria may fail to inhibit overgrowth of gram negative microorganisms resulting in the inability to isolate Group B Streptococci.
Z-1294-03 · View FDA record ↗
Registered firms
19 firms currently registered for this product code
Remel, Inc.
LENEXA, KS, US
Becton, Dickinson & Co.
SPARKS, MD, US
Chromagar
Saint-Denis Seine-Saint-Denis, FR
Lonza Verviers Srl.
Verviers Liege, BE
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Becton, Dickinson & Co.
Cockeysville, MD, US
Biomerieux France
CRAPONNE Rhone, FR
Copan Diagnostics, Inc.
Murrieta, CA, US
Analytichem Usa, Inc.
Winslow, ME, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Copan Italia
BRESCIA Lombardy, IT
Hardy Diagnostics
Orcutt, CA, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Legacy Biologicals
Baltimore, MD, US
Biomerieux Spain
Tres Cantos Madrid (Province), ES
Lonza Walkersville, Inc.
WALKERSVILLE, MD, US
Hardy Diagnostics
Springboro, OH, US
Creative Life Science Co., Ltd.
Xinzhuang District New Taipei, TW
510(k) clearances
26 clearances for this product code
- Baxter Healthcare CorpAug 15, 1988
K883075 · FASTIDIOUS INOCULUM BROTH
- Hardy MediaMar 30, 1988
K880107 · CAMPY BROTH
- Lakewood Biochemical Co., Inc.Oct 2, 1987
K873324 · SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331
- Lakewood Biochemical Co., Inc.Sep 23, 1987
K873218 · BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
- Bd Becton Dickinson Vacutainer Systems PreanalyticMay 13, 1987
K871640 · ALKALINE PEPTONE WATER
- Remel Co.May 13, 1987
K871447 · TODD HEWITT W/CNA (LIM BROTH)
- Lakewood Biochemical Co., Inc.Mar 30, 1987
K870594 · T9802 TSB W/6.5% NACL
- Apl Medical SuppliesSep 12, 1985
K853609 · APL TRYPTIC SOY BROTH