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.
FDA Recall Z-1561-2021 · Posted None
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Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeJSO
Date Initiated2021-04-22
Date Terminated2023-08-08
Product Quantity91/10-test units
Reason for Recall
The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Firm Action
The recalling firm issued customer letters dated 4/22/2021 via first class mail to its direct accounts.
Root Cause
Mixed-up of materials/components
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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