Hardy Diagnostics: Susceptibility Test Discs, Antimicrobial
Recall Summary Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30g test discs used by laboratories to determine whether certain bacteria are susceptible to the antibiotic Cefiderocol. The affected products contain incorrect cartridges that can produce inaccurate test results—showing bacteria as susceptible when they're actually resistant, or vice versa—which may lead to ineffective antibiotic treatment and worsening patient outcomes. The recalled discs were distributed nationwide to clinical laboratories and healthcare facilities.
- 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,
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-08
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/99046c81-c9c1-4651-a2b0-915ce6a5c145