HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Reported: July 9, 2025 Initiated: May 6, 2025 #Z-2041-2025
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.
Details
- Recalling Firm
- Hardy Diagnostics
- Units Affected
- 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.
- Location
- Santa Maria, CA
Frequently Asked Questions
What product was recalled? ▼
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323. Recalled by Hardy Diagnostics. Units affected: 4300 ea.
Why was this product recalled? ▼
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 9, 2025. Severity: Moderate. Recall number: Z-2041-2025.
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