HardyCHROM CRE culture medium recalled for quality control failure
Hardy Diagnostics is recalling HardyCHROM CRE culture medium because three lots failed quality control testing by allowing breakthrough growth of Klebsiella pneumoniae.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall due to quality control failure with no reported illnesses or injuries. Per the severity rubric, voluntary precautionary recalls are typically scored as Moderate (2).
Plain-English summary
HardyCHROM CRE is a selective and differential culture medium used in antimicrobial susceptibility testing. Three lots of the product failed incoming quality control testing and exhibited breakthrough growth of Klebsiella pneumoniae, which the medium is designed to suppress.
The affected lots are: 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 4,300 units were distributed to laboratories in 21 US states and territories: 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 recalled product
- Product
- HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- Manufacturer
- Hardy Diagnostics
- Hazard
- organism-breakthrough
- quality-control-failure
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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