FDA Device recall Z-2041-2025
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- FDA Device
- Class II
- ongoing
- Published 2025-07-09
On 2025-07-09 the FDA classified a Class II recall of HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323 by Hardy Diagnostics, citing identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2041-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-06 |
| Published | 2025-07-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Hardy Diagnostics |
| Distribution | AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI, WV |
Product
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.
Identifiers
| code_info | UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6, 2025; Expires on May 15, 2025 G323 lot 655101P: Manu…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2025%22
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