FDA Medical Device Recalls (openFDA)
Hardy Diagnostics: HardyDisk 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
- Recall number
- Z-2887-2026
- Recalling firm
- Hardy Diagnostics
- Product
- HardyDisk 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,
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-08-05
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- On 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
- 43 units
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
- Lot, serial or model codes
- Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
- 510(k) numbers
- ["K253105"]
- PMA numbers
- not on file
- Product code
- JTN
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28