HardyDisk Cefiderocol 30µg Susceptibility Disks
Hardy Diagnostics recalls HardyDisk Cefiderocol 30µg disks due to incorrect cartridges that may cause false susceptibility results.
Do not use the affected HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435 disks. Contact Hardy Diagnostics for instructions on returning the affected product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 43 units
Why it was recalled
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435 disks used for in vitro susceptibility testing. Incorrect cartridges included in affected products may cause false-susceptible or false-resistant results, potentially leading to ineffective antimicrobial therapy and worsening clinical outcomes.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing
- Lot code
- 543461
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Editorial summary by Recall Canary · summary updated 2026-08-06 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification