Official recall notice
FDA DeviceClass IINotable
FDA Recall: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in
- Recall date
- 2026-08-12
- Brand
- Hardy Diagnostics
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461