HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- Company
- Hardy Diagnostics
- Recall Initiated
- May 6, 2025
- Posted
- June 27, 2025
- Recall Number
- Z-2041-2025
- Quantity
- 4300 ea
- Firm Location
- Santa Maria, CA
Reason for Recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
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.
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
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.