Device product
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.
Z-1561-2021
Product summary
- Firm
- Remel Inc
- Event
- Event 87830
- Status
- Terminated
- Classification
- Class II
- Quantity
- 91/10-test units
- Official record key
device-enforcement:Z-1561-2021
Official wording
Reason: The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Code information: Lot #248035, Exp. 2021-04-27
Distribution pattern: US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.
Derived failure modes
-
Unknown
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.