Recall Z-0919-2021 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Diagnostics
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
| Date | Dec 21, 2020 |
| Status | Terminated |
| Reason | Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the strain should have been inhibited. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 820 units (82 PK10) |
| Distribution | U.S.: CA, UT, MI, Puerto Rico, IN, CT, AZ, GA, MA, TN, WA O.U.S. None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964560 | BHI W/VANCOMYCIN AGAR Hardy Diagnostics, Jan 15, 1997 |