HardyCHROM CRE (Hardy Diagnostics) – Quality Control Failure (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, CA, CO, FL, GA, IL, ME, MD, MI, MN, MO, NE, NV, NY, NC, PA, TX, UT, VA, WV, WI, PR