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Hardy Diagnostics recalls HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.
Recalled July 9, 2025 · FDA recall Z-2041-2025 · Hardy Diagnostics
Hazard
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. · FDA Class II
Units
4300 ea
Sold at
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.
Description
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
Manufacturer(s)
Hardy Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →