HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion suscep
FDA device recall Z-2887-2026 · posted 2026-08-05 · Open, Classified
Recall details
- Recalling firm
- Hardy Diagnostics
- Reason for recall
- 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.
- Action taken
- 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 respond by mail, complete, sign, and send the enclosed inventory reconciliation form (FORM-2023C) via USPS First Class Mail. To respond by email, scan and send the completed inventory reconciliation form (FORM-2023C) to TechnicalServices@HardyDiagnostics.com. 3. Replacements will be sent out at no-charge to your laboratory or a credit will be applied to invoice upon request. For Questions - contact Technical Services Department at (800) 266-2222, option 2 or via email at TechnicalServices@HardyDiagnostics.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JTN
- Quantity affected
- 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.
- Date initiated
- 2026-06-08
- Date posted
- 2026-08-05
- Location
- Santa Maria, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HardyDisk AST Cefiderocol 30µg (FDC30) (K253105) | Hardy Diagnostics | 2025-11-20 |