HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No.
FDA device recall Z-2041-2025 · posted 2025-06-27 · Open, Classified
Recall details
- Recalling firm
- Hardy Diagnostics
- Reason for recall
- Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
- Action taken
- 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. Replacements will be sent out at no-charge to your laboratory or a credit will be applied to your invoice upon request. If you have any questions, call 805-346-2766 or email: malmberga@hardydiagnostics.com.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- JSO
- Quantity 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.
- Date initiated
- 2025-05-06
- Date posted
- 2025-06-27
- Location
- Santa Maria, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HardyCHROM CRE (K190553) | Hardy Diagnostics | 2019-04-29 |