Hardy Diagnostics recalls
2 official recalls and safety alerts involving Hardy Diagnostics since 2025-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Hardy Diagnostics or the relevant agency.
- 2026-08-12
USHardy Diagnostics recalls HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
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,…
FDA · DeviceHardy DiagnosticsU.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ,…Official notice →- 2025-07-09
- US
Hardy Diagnostics recalls HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
FDA · DeviceHardy DiagnosticsUS domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD,…Official notice →