FDA Enforcement
Class II
Terminated
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.
Recall: Z-1112-2014
·
Reported March 5, 2014
Enforcement
- Recall Number
- Z-1112-2014
- Event ID
- 67415
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 5, 2014
- Initiation Date
- January 24, 2014
- Classification Date
- February 26, 2014
- Termination Date
- July 23, 2014
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519, United States
Description
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.
Reason
The product may contain high levels of microbial contamination
Code Info
Lot 1380784, Exp. 31Aug2015, and Lot 1367905, Exp. 31Jul2015
Distribution
US Distribution including Puerto Rico and the states of FL, IL, MA, ME, MI, and PA.
Quantity
44/10/500-ml. vial boxes