Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HardyCHROM CRE Recalled by Hardy Diagnostics Due to Identified lots failed incoming quality control testing. Lots...

Date: May 6, 2025
Company: Hardy Diagnostics
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hardy Diagnostics directly.

Affected Products

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

Quantity: 4300 ea

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 21 states: AZ, CA, CO, FL, GA, IL, ME, MD, MI, MN, MO, NE, NV, NY, NC, PA, TX, UT, VA, WV, WI

Affected (21 states)Not affected

About Hardy Diagnostics

Hardy Diagnostics has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report