The Recall Desk
SevereFDA (Devices)·Z-2041-2025·Announced 2025-07-09

HardyCHROM CRE Culture Medium Recalled for Quality Control Failure

Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a medical device used in clinical microbiology testing. Failure to properly inhibit Klebsiella pneumoniae could lead to incorrect antimicrobial susceptibility results, potentially affecting clinical decision-making and patient care, which meets the threshold for Severe severity.

Plain-English summary

Hardy Diagnostics is recalling HardyCHROM CRE, a selective and differential culture medium used for antimicrobial susceptibility testing. The product (Catalog No. G323, UDI-DI 008165760257704) was distributed domestically to Arizona, California, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, Nevada, New York, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Wisconsin, and West Virginia.

The recall involves three lots: lot 653594P (manufactured March 6, 2025; expires May 15, 2025), lot 655101P (manufactured April 4, 2025; expires June 13, 2025), and lot 656816P (manufactured April 16, 2025; expires June 25, 2025). A total of 4300 units were distributed.

These lots failed incoming quality control testing and exhibited breakthrough growth of Klebsiella pneumoniae, a bacterium that should be inhibited by the selective medium. This quality failure could compromise the reliability of antimicrobial susceptibility testing results.

Healthcare facilities and laboratories that received this product should stop using the affected lots immediately and contact Hardy Diagnostics for replacement products or further guidance.

The recalled product

Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Manufacturer
Hardy Diagnostics
Category
Medical Device — Diagnostic Culture Medium
Hazard
  • quality-control-failure
  • klebsiella-pneumoniae

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6
  • 2025
  • Expires on May 15
  • 2025 G323 lot 655101P: Manufactured on April 4
  • Expires on June 13
  • 2025 G323 lot 656816P: Manufactured on April 16
  • Expires on June 25

Distribution

Distributed in 22 states:

  • AZ
  • CA
  • CO
  • FL
  • GA
  • IL
  • MD
  • ME
  • MI
  • MN
  • MO
  • NC
  • NE
  • NV
  • NY
  • PA
  • PR
  • TX
  • UT
  • VA
  • WI
  • WV

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