Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Microbiology · 21 CFR 866.1700
Recent MDR events
106 adverse event reports on file
- BD BBL¿ MUELLER HINTON II AGARJan 13, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00001
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00355
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00363
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00353
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00352
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00360
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00358
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00366
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00364
- BD MUELLER HINTON II AGAR, PLATE, SQUARE, 120 MM X 20Sep 2, 2025MalfunctionBecton Dickinson Gmbh9680577-2025-00356
Event type breakdown
Recalls
8 recall events for this product code
- Remel, IncOpen, ClassifiedNov 21, 2025
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10
Products may contain contamination, which may result in a darker or brown media color.
Z-0585-2026 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJun 21, 2011
BBL" OXACILLIN SCREEN AGAR, catalog #221952, box of 10 plates.
Oxacillin Screen Agar may not have been produced according to specification and could result in false antibiotic susceptibility test results in patient specimens.
Z-2608-2011 · View FDA record ↗ - Remel, IncTerminatedJan 15, 2010
remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin, Ref R01626, 10/box. The firm name on the label is Remel, Lenexa, KS.
The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.
Z-0644-2010 · View FDA record ↗ - Trek Diagnostic SystemsTerminatedSep 30, 2009
Sensititre Mueller-Hinton Broth w/Lysed Horse Blood (MHB w/LHB), Model Number: CP112-10; Lot number 150444SA.
Thirty-one boxes of unapproved quarantine product, CP112-10 MHB w/LHB, Lot # 150444SA, were inadvertently shipped to customers on 6/2/09 instead of shipping approved Lot # 150344SA.
Z-2324-2009 · View FDA record ↗ - Trek Diagnostic SystemsTerminatedJan 28, 2009
HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.
Z-0669-2009 · View FDA record ↗ - Becton Dickinson & Co.TerminatedAug 31, 2005
Oxacillin Screen Agar, Catalog 221952, in disposable plastic media plates, packaged in boxes of 10 plates/box.
Microbiological media for antibiotic susceptibility testing gives false test results.
Z-1458-05 · View FDA record ↗ - Remel IncTerminatedUnknown
CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
Product may have incorrect cation information detailed on the product label.
Z-0209-2018 · View FDA record ↗ - Thermo FisherTerminatedUnknown
remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN
Product may fail performance testing for S aureus ATCC 43300.
Z-2137-2018 · View FDA record ↗
Registered firms
25 firms currently registered for this product code
Beckman Coulter, Inc.
West Sacramento, CA, US
Neogen Culture Media
LANSING, MI, US
Becton, Dickinson & Co.
SPARKS, MD, US
Trek Diagnostic Systems, Ltd.
East Grinstead West Sussex, GB
Becton, Dickinson & Co.
Cockeysville, MD, US
Hardy Diagnostics
Orcutt, CA, US
Remel, Inc.
LENEXA, KS, US
Remel Cleveland, A Division Of Remel Inc.
Oakwood Village, OH, US
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Hardy Diagnostics
Springboro, OH, US
510(k) clearances
74 clearances for this product code
- Edge Biologicals, Inc.Jun 30, 2014
K132491 · MUELLER HINTON AGAR
- Becton Dickinson Microbiology SystemsOct 7, 1996
K963036 · MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
- Becton Dickinson Microbiology SystemsApr 4, 1996
K960420 · MUELLER HINTON AGAR WITH 5% SHEEP BLOOD
- Remel, L.P.Mar 25, 1996
K960313 · MUELLER HINTON AGAR WITH 2% NACI
- Bioclinical Systems, Inc.Apr 4, 1995
K945911 · CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
- Carr-Scarborough Microbiologicals, Inc.Aug 24, 1994
K941985 · MUELLER HINTON AGAR W/OXACILLIN
- Lakewood Biochemical Co., Inc.Jun 28, 1988
K882351 · MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
- Hardy MediaMar 30, 1988
K880105 · MULLER HINTON BROTH