Z-2041-2025 Class II Ongoing
FDA device recall Z-2041-2025 was initiated by Hardy Diagnostics on May 6, 2025 and is designated Class II. Reason for recall: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. The recall status is ongoing. Affected quantity: 4300 ea.
Recall Details
- Product Type
- Devices
- Report Date
- July 9, 2025
- Initiation Date
- May 6, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4300 ea
Product Description
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Reason for Recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Distribution Pattern
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.
Code Information
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