FDA recall Z-1561-2021

Remel Inc · Class II · device

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

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

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