HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (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,

Class II

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.
Affected products (lot / model / serial): Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
Units affected: 43 units
Distribution pattern: U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
Firm location: Santa Maria, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2887-2026
Recall initiated: June 8, 2026
FDA classification date: August 5, 2026
FDA report date: August 12, 2026
FDA event ID: 99226
Last updated on HTM Vibe: August 18, 2026