Reported Jul 9, 2025 · Ongoing

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

Hardy Diagnostics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hardy Diagnostics · 1430 W McCoy Ln · Santa Maria, CA · 93455-1005

Is this the product you have?

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

4 of 4 products

Products covered by this recall
#Product as published
1Manufactured on March 6, 2025
2Expires on May 15, 2025 G323 lot 655101P: Manufactured on April 4, 2025
3Expires on June 13, 2025 G323 lot 656816P: Manufactured on April 16, 2025
4Expires on June 25, 2025
Amount recalled
4300 ea

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:13 PM UTC

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