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U.S. Department of Health and Human Services

Class 2 Device Recall HardyDisk AST Cefiderocol 30g (FDC30)

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 Class 2 Device Recall HardyDisk AST Cefiderocol 30g (FDC30)see related information
Date Initiated by FirmJune 08, 2026
Date PostedAugust 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2887-2026
Recall Event ID 99226
510(K)NumberK253105 
Product Classification Susceptibility test discs, antimicrobial - Product Code JTN
ProductHardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to Cefiderocol,
Code Information Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
FEI Number 2022807
Recalling Firm/
Manufacturer		 Hardy Diagnostics
1430 W McCoy Ln
Santa Maria CA 93455-1005
For Additional Information ContactCaley Thompson
805-346-2766 Ext. 5786
Manufacturer Reason
for Recall		Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 06/08/2026 an "URGENT: Medical Device Recall Notification" was sent via First Class Mail and Email and/or Facsimile to customer informing them that as a result of receiving a customer complaint/report, it was confirmed that antibiotic disk cartridges labeled as HardyDisk AST Cefiderocol (disk code FDC30) were found to contain sporadic disks labeled with Piperacillin/Tazobactam disk code (TZP110). Customers are instructed to: 1. Discard any remaining stock. 2. Response to this notification is requested within 5 business days of receipt of this letter, either through mail or email. To respond by mail, complete, sign, and send the enclosed inventory reconciliation form (FORM-2023C) via USPS First Class Mail. To respond by email, scan and send the completed inventory reconciliation form (FORM-2023C) to TechnicalServices@HardyDiagnostics.com. 3. Replacements will be sent out at no-charge to your laboratory or a credit will be applied to invoice upon request. For Questions - contact Technical Services Department at (800) 266-2222, option 2 or via email at TechnicalServices@HardyDiagnostics.com.
Quantity in Commerce43 units
DistributionU.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
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 = JTN
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