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Remel Inc Recall 87830

Description: 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.

Remel Inc Recall 87830 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1561-2021
Event ID87830
Event DescriptionRemel 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.
Product TypeDevices
DistributionUS 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.
Quantity91/10-test units
Recall ReasonThe media allows growth of E. faecalis ATCC 29212 with blackening of the media.
Device Classification20210519
Device Code InfoLot #248035, Exp. 2021-04-27
Center Classification Date20210512
Recall Initiation Date20210422
Recalling FirmRemel Inc
Initial Notification Letter
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