# FDA recall Z-1561-2021

> **Remel Inc** · Class II · device recall initiated 2021-04-22.

## 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 for recall

The media allows growth of E. faecalis ATCC 29212 with blackening of the media.

## 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.

## Key facts

- **Recall number:** Z-1561-2021
- **Recalling firm:** Remel Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-22
- **Report date:** 2021-05-19
- **Termination date:** 2023-08-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lenexa, KS, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2021

## Citation

> AI Analytics. FDA recall Z-1561-2021. Retrieved 2026-08-13 from https://api.ai-analytics.org/recall/Z-1561-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*