Hardy Diagnostics recalls HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.…

Recall date

May 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2041-2025

FDA classification

Class II

Brand / firm

Hardy Diagnostics

Sold / distributed

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.

Why it was recalled

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323