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Recall Observatory FDA recall evidence

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.

Z-1561-2021

April 22, 2021

Class II

Product summary

Firm
Remel Inc
Event
Event 87830
Status
Terminated
Classification
Class II
Quantity
91/10-test units
Official record key
device-enforcement:Z-1561-2021

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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