FDA Medical Device Recalls (openFDA)
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 number
- Z-0919-2021
- 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
- Status
- Terminated
- Initiated
- 2020-12-21
- Posted
- not on file
- Terminated
- 2022-09-28
- Reason
- Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
- 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 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
- Quantity
- 820 units (82 PK10)
- Distribution
- U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
- Lot, serial or model codes
- Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
- 510(k) numbers
- ["K964560"]
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28