Device product
Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental samples. When the product is added to CYE Agar base, it stabilizes pH and provides essential growth factors for the isolation of the Legionella spp.
Z-1112-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 67415
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44/10/500-ml. vial boxes
- Official record key
device-enforcement:Z-1112-2014
Official wording
Reason: The product may contain high levels of microbial contamination
Code information: Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015
Distribution pattern: US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
Derived failure modes
-
Microbial contamination
microbial contamination