Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30μg FDC30 (REF Z9435) for false susceptibility results in antibiotic testing, potentially causing ineffective treatment. Affected units may lead to delayed treatment or worsened infections.
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.
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30μg FDC30 (REF Z9435) because incorrect cartridges in some units can cause false susceptibility results. This might lead to ineffective antibiotic treatment, delayed care, or worse infection outcomes.
The recalled product uses incorrect cartridges that may produce false results. This could mean antibiotics are chosen that don't work, leading to treatment delays or worse infections.
Healthcare professionals using this product for antibiotic susceptibility testing are most at risk. Patients relying on accurate test results for treatment decisions could be affected.
Check for the product name 'HardyDisk AST Cefiderocol 30μg FDC30' with reference number Z9435. The product was sold with lot number 543461.
Verify the reference number Z94335 and lot number 543461 on the product label.
The product may include incorrect cartridges that cause false susceptibility results, potentially leading to ineffective antibiotic treatment.
Using the recalled product could result in false antibiotic susceptibility results, which might delay appropriate treatment or worsen infections.
Look for the reference number Z9435 and lot number 543461 on the product label.
We’ve drafted a message you can send Hardy Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2887-2026 — Hardy Diagnostics Hardy Diagnostics Hello, I own a Hardy Diagnostics that is covered by recall Z-2887-2026 from Hardy Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
