DeviceSignal · Recall classified
Hardy Diagnostics
FDA classified a device recall on 2026-08-05 · Class II · Z-2887-2026
EventRecall classified
Effective2026-08-05
ClassificationClass II
On 2026-08-05 the FDA classified a device recall from Hardy Diagnostics as Class II. Product: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g…. Recall Z-2887-2026. The firm initiated it on 2026-06-08. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2887-2026
- Classification
- Class II
- Classified on
- 2026-08-05
- Initiated on
- 2026-06-08
- Firm
- Hardy Diagnostics
- 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.
- Product
- HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (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,
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2887-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
7cba817d4b38d95caf4f6afac17f11ce79d6cba7e6bb152f7687ba1b634be203- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)