PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 3, 2021 Initiated: December 21, 2020 #Z-0919-2021

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.

Details

Recalling Firm
Hardy Diagnostics
Units Affected
820 units (82 PK10)
Distribution
U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Location
Santa Maria, CA

Frequently Asked Questions

What product was recalled?
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. Recalled by Hardy Diagnostics. Units affected: 820 units (82 PK10).
Why was this product recalled?
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0919-2021.