Device product
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar 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.
Z-0974-2015
Product summary
- Event
- Event 69091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,617 cases (100 plates/case)
- Official record key
device-enforcement:Z-0974-2015
Official wording
Reason: A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
Code information: Catalogue # 221291 with Lot #4050354, 4086399, 4099206 and 4143653; Catalogue #221261 with Lot # 4022158 4086443 4092199
Distribution pattern: Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Derived failure modes
-
Microbial contamination
contamination of Listeria monocytogenes