Hardy Diagnostics: Device Recall
Recall #Z-2041-2025 · 05/06/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2041-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Hardy Diagnostics
- Status
- Ongoing
- Date Initiated
- 05/06/2025
- Location
- Santa Maria, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4300 ea
Reason for Recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Product Description
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.