Hardy Diagnostics: Medical Device Recall in 2021 - (Recall #: Z-0919-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 21, 2020

Date Posted: February 3, 2021

Recall Number: Z-0919-2021

Event ID: 87091

Reason for Recall:

Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.

Status: Terminated

Product Quantity: 820 units (82 PK10)

Code Information:

Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698

Distribution Pattern:

U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None

Voluntary or Mandated:

Voluntary: Firm initiated