Hardy Diagnostics Recall 87091
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
Hardy Diagnostics Recall 87091 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0919-2021 |
| Event ID | 87091 |
| Event 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 |
| Product Type | Devices |
| Distribution | U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None |
| Quantity | 820 units (82 PK10) |
| Recall Reason | Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. |
| Device Classification | 20210203 |
| Device Code Info | Catalog Number: G14 UDI Code: 00816576020102 Lot Number: 472698 |
| Center Classification Date | 20210125 |
| Recall Initiation Date | 20201221 |
| Recalling Firm | Hardy Diagnostics |
| Initial Notification | Letter |
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