Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no:… recallZ-0919-2021 · Hardy Diagnostics · initiated Dec 21, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hardy Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0919-2021
- Status
- Terminated
- Initiated by the company
- Dec 21, 2020
- Recalling firm
- Hardy Diagnostics
- Quantity
- 820 units (82 PK10)
- Product code
- JSO
- FDA submissions
- K964560
- Distribution
- U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None
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
Code information (models, lots, serial numbers)
Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA G14Hardy Diagnostics · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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