Z-2887-2026Class II

HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar...

Name: Z-2887-2026 HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar...
Creator: Hardy Diagnostics
Published: 2026-06-08
License: https://open.fda.gov/license/

Hardy Diagnostics / initiated 2026-06-08 / Open, Classified

FDA source

Hardy Diagnostics began a recall of HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when... on 2026-06-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2887-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-08
Posted: 2026-08-05
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,
Product code: JTN Susceptibility Test Discs, Antimicrobial
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 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 [email protected]. 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2887-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2887-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-05

Product code JTN

K253105Class IIHardyDisk AST Cefiderocol 30µg (FDC30)Hardy Diagnostics / cleared 2025-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)