Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-1...
FDA Recall #Z-0919-2021 — Class II — December 21, 2020
Product Description
Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
Reason for Recall
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Recalling Firm
Hardy Diagnostics — Santa Maria, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
820 units (82 PK10)
Distribution
U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Code Information
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated