Hardy Diagnostics recalls HardyDisk AST Cefiderocol 30μg FDC30 (REF Z9435) for false susceptibility results in antibiotic testing, potentially causing ineffective treatment. Affected units may lead to delayed treatment or worsened infections.
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.
“HardyDisk AST Cefiderocol 30μg FDC30: False Susceptibility Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314418-hardydisk-ast-cefiderocol-30-g-fdc30-false-susceptibility-results-risk. Based on FDA recall #Z-2887-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2887-2026%22&limit=1).
The FDA announced on June 8, 2026, that Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 due to the potential for false susceptibility results. The agency stated the recall addresses incorrect cartridges included in affected products.
How to tell if you have it
Brand: Hardy Diagnostics
Product: HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion
REF: Z9435
UD-DI code: Pending
Lot Number: 543461
The hazard
The recall addresses the potential for false-susceptible or false-resistant susceptibility results due to incorrect cartridges. This error may lead to the selection of ineffective antimicrobial therapy, potentially resulting in delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
Context
GovInfoNow's records show Hardy Diagnostics has issued six other recalls since November 14, 2019. Recent brand recalls include the May 6, 2025, HardyCHROM CRE Culture Media Recall and the April 16, 2021, Quickslide GramPro 1 Microscope Slide Stainer Recall. Other recent recalls of similar products include the June 4, 2026, Biomerieux VITEK 2 AST-N447 Kit Recall and the July 24, 2026, Biomerieux VITEK 2 AST-N461 Test Kit Recall.
How to tell if you have this one
Check for the product name 'HardyDisk AST Cefiderocol 30μg FDC30' with reference number Z9435. The product was sold with lot number 543461.
Brand
Hardy Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the reference number Z94335 and lot number 543461 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Idaho, Indiana, Massachusetts, Mississippi, Nevada, New Jersey, New York, Ohio, Pennsylvania, Tennessee.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2887-2026 (June 8, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2887-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.