Culture Media, Selective And Differential
FDA adverse event reports and recall history for culture media, selective and differential (product code JSI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 298
- Deaths
- 0
- Injuries
- 4
- Malfunctions
- 293
Reports per year
Source: FDA adverse event reports by year received, 1997–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-07-31Open, ClassifiedUnder Investigation by firm
Strep Selective II Agar, Product Number R01859
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-07-31Open, ClassifiedUnder Investigation by firm
Blood/EMB, Levine 100/PK, Product Number R02041
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-07-31Open, ClassifiedUnder Investigation by firm
Blood/MacConkey Biplate 100/PK, Product Number R02049
The products may contain surface and subsurface contamination of Listeria monocytogenes.
- 2025-05-27Open, ClassifiedStorage
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.
- 2025-02-20Open, ClassifiedUnder Investigation by firm
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.
- 2025-02-20Open, ClassifiedUnder Investigation by firm
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.
- 2023-01-04Open, ClassifiedStorage
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
- 2023-01-04Open, ClassifiedStorage
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
- 2016-04-22TerminatedMaterial/Component Contamination
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
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.
- 2016-04-01TerminatedNo Marketing Application
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).
Product marketed without a 510 (k)
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