[pending] HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing,
Pending LLM rewrite. Source: FDA_DEVICE Z-2041-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
The recalled product
- Product
- HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- Manufacturer
- Hardy Diagnostics
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6
- 2025
- Expires on May 15
- 2025 G323 lot 655101P: Manufactured on April 4
- Expires on June 13
- 2025 G323 lot 656816P: Manufactured on April 16
- Expires on June 25
Distribution
Distributed in 22 states:
- AZ
- CA
- CO
- FL
- GA
- IL
- MD
- ME
- MI
- MN
- MO
- NC
- NE
- NV
- NY
- PA
- PR
- TX
- UT
- VA
- WI
- WV
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