Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Microbiology · 21 CFR 866.1700
Recent MDR events
762 adverse event reports on file
- BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SAJun 18, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00031
- BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SAJun 18, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00032
- BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SAJun 18, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00033
- BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SAApr 14, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00028
- BD BBL¿ CHROMAGAR® MRSA IIMar 19, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00023
- BD BBL¿ CHROMAGAR® MRSA IIMar 19, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00024
- BD BBL¿ CHROMAGAR® MRSA IIMar 19, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00026
- BD BBL¿ CHROMAGAR® MRSA IIMar 19, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00025
- BD BBL¿ CHROMAGAR® MRSA IIMar 19, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00027
- BD BBL¿ CHROMAGAR¿ MRSA II / CHROMAGAR¿ SAMar 18, 2026MalfunctionBecton Dickinson Gmbh9680577-2026-00008
Event type breakdown
Recalls
56 recall events for this product code
- Hardy DiagnosticsOpen, ClassifiedJun 27, 2025
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Z-2041-2025 · View FDA record ↗ - Remel, IncOpen, ClassifiedJun 29, 2023
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use
The test medium may not perform as intended.
Z-2038-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0802-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0803-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM INDUSTRY COMBOURG LPT BROTH (4X3L), CATALOG 410849
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0813-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0839-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0842-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0844-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 419014
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0845-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0858-2023 · View FDA record ↗
Registered firms
32 firms currently registered for this product code
Biomerieux France
CRAPONNE Rhone, FR
Becton, Dickinson & Co.
SPARKS, MD, US
Remel, Inc.
LENEXA, KS, US
Biomerieux Sa
Combourg Ille-et-Vilaine, FR
Biomerieux Spain
Tres Cantos Madrid (Province), ES
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Hardy Diagnostics
Orcutt, CA, US
Hardy Diagnostics
Springboro, OH, US
Bio-rad Service France Sas
Mitry Mory Ile-de-France, FR
Bio-rad
STEENVOORDE Nord, FR
Becton, Dickinson & Co.
Cockeysville, MD, US
510(k) clearances
40 clearances for this product code
- Hardy DiagnosticsApr 29, 2019
K190553 · HardyCHROM CRE
- Biomerieux S.A.Jul 6, 2018
K181092 · CHROMID CARBA agar (CARB)
- Bio-RadDec 28, 2017
K171061 · MRSASelect II
- Remel, Inc.May 1, 2017
K162620 · Remel Spectra ESBL
- Hardy DiagnosticsNov 15, 2016
K160512 · HardyCHROM ESBL
- bioMerieux, Inc.Oct 25, 2016
K162076 · chromID MRSA
- bioMerieux, Inc.Mar 11, 2016
K151688 · chromID MRSA
- Bio-RadNov 6, 2012
K122187 · VRESELECT CULTURE MEDIUM