Hardy Diagnostics recalls

Recall found. Hardy Diagnostics is named in FDA Class II recall Z-2887-2026 covering HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo. 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. Identifying details: Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461. Status: Ongoing.

Models with recalls

HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo (1)

All Hardy Diagnostics recalls

FDA Class II · Medical device · August 12, 2026

HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo recall — Hardy Diagnostics

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…

Official ID Z-2887-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.