Device product
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
Z-1805-2013
Product summary
- Event
- Event 65614
- Status
- Terminated
- Classification
- Class II
- Quantity
- 293 cartons
- Official record key
device-enforcement:Z-1805-2013
Official wording
Reason: Microbiological identification media may exhibit reduced levels of Vancomycin.
Code information: Lot 3078430 Exp 5/30/13
Distribution pattern: Worldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
Derived failure modes
-
Unknown
Microbiological identification media may exhibit reduced levels of Vancomycin.