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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
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
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