OVERLOOKED

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Class IIOngoing

Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diff

Recall date · record updated Aug 12, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Hardy Diagnostics
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99226…

Products

  1. 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,

    Codes/lots: Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461Quantity: 43 unitsRecall no. Z-2887-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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