Hardy Diagnostics 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Hardy Diagnostics
Lot Codes / Batch Numbers
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Products Sold
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Hardy Diagnostics is recalling Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-2 due to Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Recommended Action
Per FDA guidance
On 12/21/2020, the firm sent an "URGENT: Medical Device Recall Notification" letter to customers via first class mail, email and/or facsimile informing them that seven customer complaints received of breakthrough of negative controls. Customers are instructed to: 1. Discard any remaining stock. The product should be destroyed according to local regulation as non-hazardous waste if un-inoculated, or as medical waste if inoculated. 2. Retain the Recall Notification and to notify any and all employees who may use the product. If the product was further distributed, to notify the consignees the product was distributed to. 3. Fill out the Product Recall Customer Inventory Form and to return the form within five (5) business days via e-mail to JohnsonL@HardyDiagnostics.com or by fax to (805)266-2222, option 2 or (805)361-5050 or via e-mail at TechnicalServices@HaryDiagnostics.com. For any questions or further information contact Technical Services Department at 800-266-2222 ext. 5598
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CT, GA, IN, MA, MI, TN, UT, WA, PR
Page updated: Jan 10, 2026