Recall Z-2887-2026 · JTN Susceptibility Test Discs, Antimicrobial
Hardy Diagnostics
HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,
| Date | Aug 5, 2026 (initiated Jun 8, 2026) |
| Status | Open, Classified |
| Reason | Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome. |
| Root cause | Under Investigation by firm |
| Action | On 06/08/2026 an "URGENT: Medical Device Recall Notification" was sent via First Class Mail and Email and/or Facsimile to customer informing them that as a result of receiving a customer complaint/report, it was confirmed that antibiotic disk cartridges labeled as HardyDisk AST Cefiderocol (disk code FDC30) were found to contain sporadic disks labeled with Piperacillin/Tazobactam disk code (TZP110). Customers are instructed to: 1. Discard any remaining stock. 2. Response to this notification is requested within 5 business days of receipt of this letter, either through mail or email. To respon |
| Quantity | 43 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K253105 | HardyDisk AST Cefiderocol 30µg (FDC30) Hardy Diagnostics, Nov 20, 2025 |