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Can cause harm that is usually temporary.

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,

Check the device or its packaging for

Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
Why
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.
Distributed
U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
Company
Hardy Diagnostics
Announced
This is the date the recall was announced. A company may have started it weeks earlier.
Recall began

Source: FDA record Z-2887-2026 · retrieved 5 August 2026

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