Remel Inc Recall 87830
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.
Remel Inc Recall 87830 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1561-2021 |
| Event ID | 87830 |
| Event 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. |
| Product Type | Devices |
| 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 |
| Recall Reason | The media allows growth of E. faecalis ATCC 29212 with blackening of the media. |
| Device Classification | 20210519 |
| Device Code Info | Lot #248035, Exp. 2021-04-27 |
| Center Classification Date | 20210512 |
| Recall Initiation Date | 20210422 |
| Recalling Firm | Remel Inc |
| Initial Notification | Letter |
| Similar To |