Recall Z-2041-2025 ยท JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Hardy Diagnostics
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
| Date | Jun 27, 2025 (initiated May 6, 2025) |
| Status | Open, Classified |
| Reason | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae. |
| Root cause | Nonconforming Material/Component |
| Action | On May 6, 2025, the firm began notifying customers via "URGENT Medical Device Recall Notification" letters. Customers were instructed to discard any remaining stock and to destroy it according to local regulations. If product was further distributed, notify the consignees who received the product. Please retain this letter or post the letter where the product is stored to ensure the users are aware of this defect. For replacements or credit, please contact the firm's Technical Services Department at (800) 266-2222, option 2 or via email at TechnicalServices@HardyDiagnostics.com. Replacemen |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190553 | HardyCHROM CRE Hardy Diagnostics, Apr 29, 2019 |