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U.S. Department of Health and Human Services

Class 2 Device Recall HardyCHROM CRE

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 Class 2 Device Recall HardyCHROM CREsee related information
Date Initiated by FirmMay 06, 2025
Date PostedJune 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2041-2025
Recall Event ID 96843
510(K)NumberK190553 
Product Classification Culture media, antimicrobial susceptibility test, excluding mueller hinton agar - Product Code JSO
ProductHardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Code Information 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
FEI Number 2022807
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information ContactAllie Malmberg
805-346-2766 Ext. 5716
Manufacturer Reason
for Recall		Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce4300 ea
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JSO
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