RecallDepth

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.

Company
Remel Inc
Recall Initiated
April 22, 2021
Terminated
August 8, 2023
Recall Number
Z-1561-2021
Quantity
91/10-test units
Firm Location
Lenexa, KS

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.

Lot / Code Info

Lot #248035, Exp. 2021-04-27

Root Cause

Mixed-up of materials/components

Action Taken

The recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts.

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