Hardy Diagnostics recalls HardyCHROM CRE

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

HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323

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.

• FDA enforcement recordOfficial FDA database entry for Z-2041-2025
• FDA 510(k) clearance · K190553The device's official FDA premarket clearance record
• FDA device classification · JSOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1700The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hardy DiagnosticsSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.