HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Recall Z-2041-2025 · Posted 2025-06-27
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Recalling FirmHardy Diagnostics
Recall StatusOpen, Classified
Product CodeJSO
Date Initiated2025-05-06
Product Quantity4300 ea
Reason for Recall
Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
Firm Action
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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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