Official recall record
HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30µg (FDC30) for in vitro agar diffusion susceptibility test
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-06-08
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Hardy Diagnostics
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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