Remel Inc: Medical Device Recall in 2021 - (Recall #: Z-1561-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: April 22, 2021

Date Posted: May 19, 2021

Recall Number: Z-1561-2021

Event ID: 87830

Reason for Recall:

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

Status: Terminated

Product Quantity: 91/10-test units

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.

Voluntary or Mandated:

Voluntary: Firm initiated