FDA Enforcement
Class II
Ongoing
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Recall: Z-2041-2025
·
Reported July 9, 2025
Enforcement
- Recall Number
- Z-2041-2025
- Event ID
- 96843
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hardy Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 9, 2025
- Initiation Date
- May 6, 2025
- Classification Date
- June 27, 2025
- Address
- 1430 W McCoy Ln, Santa Maria, CA, 93455-1005, United States
Description
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Reason
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Code Info
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
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.
Quantity
4300 ea