Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no:… — Class II medical device recall Z-0919-2021
Terminated recall by Hardy Diagnostics, reported 2021-02-03, distributed in AZ, CA, CT, GA, IN, MA, MI, PR…. Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should h
| Recall number | Z-0919-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hardy Diagnostics, Santa Maria, CA, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-01-25 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2022-09-28 |
| Distributed | AZ, CA, CT, GA, IN, MA, MI, PR, TN, UT, WA |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00816576020102 |
| Lot numbers | 472698 |
| Model numbers | G14 |
| Expiration dates | 2020-12-28 |
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
Reason for recall
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0919-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.