Culture Media, Selective And Differential
Microbiology · 21 CFR 866.2360
Recent MDR events
298 adverse event reports on file
- CHROMID® CANDIDAJun 10, 2026MalfunctionBiomérieux Sa9615755-2026-00001
- BD BBL¿ MACCONKEY AGARJan 6, 2026MalfunctionBd Cuautitlan9614033-2025-00128
- BD BBL¿ MACCONKEY II AGARDec 8, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-05483
- CHROMID® CANDIDANov 3, 2025MalfunctionBiomérieux Sa9615755-2025-00002
- CHROMID® CANDIDAOct 2, 2025MalfunctionBiomérieux Sa9615755-2025-00001
- BD BBL¿ CHROMAGAR¿ CANDIDASep 3, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04855
- BD BBL¿ CHROMAGAR¿ CANDIDASep 3, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04850
- BD BBL¿ CHROMAGAR¿ CANDIDASep 3, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04851
- BD BBL¿ CHROMAGAR¿ CANDIDASep 3, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04852
- BD BBL¿ CHROMAGAR¿ CANDIDASep 3, 2025MalfunctionBecton Dickinson & Co. (sparks)1119779-2025-04853
Event type breakdown
Recalls
24 recall events for this product code
- Remel, IncOpen, ClassifiedJul 31, 2025
Strep Selective II Agar, Product Number R01859
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2224-2025 · View FDA record ↗ - Remel, IncOpen, ClassifiedJul 31, 2025
Blood/EMB, Levine 100/PK, Product Number R02041
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2225-2025 · View FDA record ↗ - Remel, IncOpen, ClassifiedJul 31, 2025
Blood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Z-2226-2025 · View FDA record ↗ - Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedMay 27, 2025
BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1829-2025 · View FDA record ↗ - Remel, IncOpen, ClassifiedFeb 20, 2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Z-1200-2025 · View FDA record ↗ - Remel, IncOpen, ClassifiedFeb 20, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Z-1201-2025 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0801-2023 · View FDA record ↗ - Biomerieux IncOpen, ClassifiedJan 4, 2023
PPM CLINICAL CRAPONNE CHROMID C.DIFFICILE 20 PLT, CATALOG 43871
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Z-0804-2023 · View FDA record ↗ - Becton Dickinson & Co.TerminatedApr 22, 2016
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar is contaminated with Listeria Monocytogenes. The device is a non-sterile prepared plated media.
Z-1559-2016 · View FDA record ↗ - Northeast Laboratory Services, Inc.TerminatedApr 1, 2016
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish)
Product marketed without a 510 (k)
Z-1313-2016 · View FDA record ↗
Registered firms
42 firms currently registered for this product code
Remel, Inc.
LENEXA, KS, US
Ssi Diagnostica A/s
Hilleroed Hovedstaden, DK
K&r Technologies Dba Microbiology International
Frederick, MD, US
Analytichem Usa, Inc.
Winslow, ME, US
Aidian Oy
ESPOO Uusimaa, FI
Becton, Dickinson & Co.
Cockeysville, MD, US
Savyon Diagnostics Ltd.
ASHDOD Southern, IL
Bio-rad Service France Sas
Mitry Mory Ile-de-France, FR
Biomerieux France
CRAPONNE Rhone, FR
Oxoid, Ltd.
BASINGSTOKE, HAMPSHIRE, GB
Diagnostic Consulting Network, Llc.
Carlsbad, CA, US
Biomerieux Sa
Combourg Ille-et-Vilaine, FR
Lifesign L.l.c.
Skillman, NJ, US
Legacy Biologicals
Baltimore, MD, US
Key Scientific Products
Stamford, TX, US
Himedia Laboratories Private Limited
DOMBIVLI, THANE Maharashtra, IN
Becton, Dickinson & Co.
SPARKS, MD, US
Himedia Laboratories Private Limited
NASHIK Maharashtra, IN
Hardy Diagnostics
Orcutt, CA, US
510(k) clearances
285 clearances for this product code
- Becton, Dickinson & CONov 20, 2007
K070691 · BBL CHROMAGAR 0157
- Novamed , Ltd.Jul 30, 1998
K974428 · DIPSTREAK
- Oxoid U.S.A., Inc.Jun 9, 1989
K891593 · LISTERIA SELECTIVE ENRICHMENT MEDIUM
- Orion Corp.Mar 2, 1989
K890199 · DENTOCULT SM-STRIP MUTANS
- Lakewood Biochemical Co., Inc.Jun 6, 1988
K882182 · SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
- Acumedia Manufacturers, Inc.Apr 18, 1988
K881556 · TRICHOMONAS BROTH
- Acumedia Manufacturers, Inc.Apr 18, 1988
K881572 · XL AGAR BASE
- Acumedia Manufacturers, Inc.Apr 18, 1988
K881576 · SELENITE BROTH