FDA Recall
Terminated
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.
Recall: Z-1561-2021
·
Initiated April 22, 2021
Recall
- Recall Number
- Z-1561-2021
- Event Number
- 87830
- Firm
- Remel Inc
- FEI Number
- 1924669
- Product Code
- JSO
- Status
- Terminated
- Root Cause
- Mixed-up of materials/components
- Initiated
- April 22, 2021
- Terminated
- August 8, 2023
- Address
- 12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519
Description
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.
Reason
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Action
The recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts.
Distribution
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.
Quantity
91/10-test units