FDA Device recall Z-1561-2021
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screen…
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screen… by Remel, citing the media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1561-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-22 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remel |
| Distribution | US |
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.
Reason
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Identifiers
| code_info | Lot #248035, Exp. 2021-04-27 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2021%22
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