[Recalled] 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 — Complaints were received reporting of Staphylococcus aureus (ATCC 2
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Hardy Diagnostics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0919-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 December 2020 |
| EAN / barcode | 00816576020102 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Hardy Diagnostics
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.