The Recall Desk
ModerateFDA (Devices)·Z-1561-2021·Announced 2021-05-19

Remel Bile Esculin Azide Agar Recalled for Growth of E. faecalis

Remel Inc is recalling Bile Esculin Azide Agar with Vancomycin because the media allows growth of E. faecalis ATCC 29212.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the use of the product may cause temporary or medically reversible health consequences, or where there is a remote probability of serious adverse health consequences. The specific defect is a performance issue (growth of E. faecalis) rather than a direct physical hazard like fire or shock.

Plain-English summary

Remel Inc is recalling Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186. The product is used in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-resistance enterococci (VRE) from surveillance cultures.

The recall was initiated because the media allows growth of E. faecalis ATCC 29212 with blackening of the media. This performance issue may affect the accuracy of the screening method.

The affected lot is #248035 with an expiration date of 2021-04-27. The product was distributed nationwide in the United States to 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. Users should stop using the affected product and contact Remel Inc for further instructions.

The recalled product

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.
Manufacturer
Remel Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #248035
  • Exp. 2021-04-27

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically: