FDA Enforcement
Class II
Terminated
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen.
Recall: Z-1803-2013
·
Reported July 31, 2013
Enforcement
- Recall Number
- Z-1803-2013
- Event ID
- 65614
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 31, 2013
- Initiation Date
- June 6, 2013
- Classification Date
- July 24, 2013
- Termination Date
- September 3, 2013
- Address
- BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD, 21152-0999, United States
Description
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen.
Reason
Microbiological identification media may exhibit reduced levels of Vancomycin.
Code Info
Lot 3078280 Exp 6/27/13
Distribution
Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Quantity
92 cartons