FDA Device recall Z-2887-2026
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing…
- FDA Device
- Class II
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class II recall of HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing… by Hardy Diagnostics, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2887-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-08 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Hardy Diagnostics |
| Distribution | US |
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,
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.
Identifiers
| code_info | Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Other recalls by Hardy Diagnostics
- HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
FDA Device · Class II · 2025-07-09 · Hardy Diagnostics - Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer
FDA Device · Class II · 2021-06-16 · Hardy Diagnostics - Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 1…
FDA Device · Class II · 2021-02-03 · Hardy Diagnostics - Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centri…
FDA Device · Class II · 2020-12-30 · Hardy Diagnostics - Strep B Carrot Broth One-Step, Ref
FDA Device · Class III · 2020-11-18 · Hardy Diagnostics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2887-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.