Hardy Diagnostics: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility test
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Hardy Diagnostics
- Product
- 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,
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
- Recall initiated
- 2026-06-08
- Code info
- Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
- Product quantity
- 43 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Santa Maria
- State
- CA
- Country
- United States
- Event id
- 99226
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