Z-0919-2021Class II

Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29...

Name: Z-0919-2021 Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29...
Creator: Hardy Diagnostics
Published: 2020-12-21
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2020-12-21 / Terminated

FDA source

Hardy Diagnostics began a recall of 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 on 2020-12-21. FDA classified it as Class II and gives the reason as "Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0919-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Posted: 2021-01-25
Terminated: 2022-09-28
Recalling firm: Hardy Diagnostics
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
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
FDA root cause: Under Investigation by firm
Action: 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 [email protected] or by fax to (805)266-2222, option 2 or (805)361-5050 or via e-mail at [email protected]. For any questions or further information contact Technical Services Department at 800-266-2222 ext. 5598
Quantity in commerce: 820 units (82 PK10)
Distribution: U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
Product codes and lots: Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-03	2021-01-25

Product code JSO

K964560Class IIBhi W/vancomycin AgarHardy Diagnostics / cleared 1997-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)