FDA Device recall Z-0919-2021
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: 1…
- FDA Device
- Class II
- terminated
- Published 2021-02-03
On 2021-02-03 the FDA classified a Class II 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: 1… by Hardy Diagnostics, citing complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0919-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-21 |
| Published | 2021-02-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Hardy Diagnostics |
| Distribution | AZ, CA, CT, GA, IN, MA, MI, PR, TN, UT, WA |
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
Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
Identifiers
| code_info | Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.