HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Recall
- Recall Number
- Z-2041-2025
- Event Number
- 96843
- Firm
- Hardy Diagnostics
- FEI Number
- 2022807
- Product Code
- JSO
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 6, 2025
- Posted
- June 27, 2025
- Address
- 1430 W McCoy Ln, Santa Maria, CA, 93455-1005
Description
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
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 [email protected]. 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: [email protected].
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.
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