Device product
Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.
Z-0976-2015
Product summary
- Event
- Event 69091
- Status
- Terminated
- Classification
- Class II
- Quantity
- 775 cases
- Official record key
device-enforcement:Z-0976-2015
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 # 221263 with Lot #4099228
Distribution pattern: Worldwide Distribution - US nationwide including Puerto Rico, Belgium, Canada, Philippines, Singapore, and Taiwan.
Derived failure modes
-
Microbial contamination
contamination of Listeria monocytogenes