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 | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. |
| Product | HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 |
| Quantity | 4300 ea |
| Distribution | US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV. |
| Initiated | 2025-05-06 |
| Classified | 2025-06-27 |
| Recall number | Z-2041-2025 |
| 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-2041-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96843/
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