HardyCHROM CRE recall
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Why was HardyCHROM CRE recalled?
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6, 2025; Expires on May 15, 2025 G323 lot 655101P: Manufactured on April 4, 2025; Expires on June 13, 2025 G323 lot 656816P: Manufactured on April 16, 2025; Expires on June 25, 2025
- Product
- HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- Recalling firm
- Hardy Diagnostics
- Quantity
- 4300 ea
- Distribution
- 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.
- Recall date
- July 9, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)