FDAFDA · Food and drugs·Recall number Z-2887-2026
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,
Published August 12, 2026 · Recall initiated: June 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hardy Diagnostics
- Distributor
- U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
- Lot
- Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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