Recall archive / FDA device enforcement
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog N... — FDA record Z-2041-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Hardy Diagnostics
- Quantity
- 4300 ea
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2041-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 9, 2025
- Recall initiation date
- May 6, 2025
- Center classification date
- Jun 27, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.