Class II — Hardy Diagnostics
| Recalling firm | HARDY DIAGNOSTICS |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (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, |
| Quantity | 43 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN. |
| Initiated | 2026-06-08 |
| Classified | 2026-08-05 |
| Recall number | Z-2887-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hardy Diagnostics (Z-2887-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99226/
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