Hardy Diagnostics cefiderocol disks recalled for false result risk
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30 µg (catalog Z9435) because incorrect cartridges were included in some units. This may lead to false-susceptible or false-resistant results, which could result in an ineffective antimicrobial being chosen. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside any units from lot 543461 and do not use them for susceptibility testing.
- Check the catalog number (Z9435) and lot number (543461) on the package to identify affected units.
- Contact Hardy Diagnostics. The notice does not specify a remedy.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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,
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 43 units
- Illnesses reported
- None reported
- Manufactured in
- 1430 W McCoy Ln, Santa Maria, CA, United States
- Classification
- Class II
- Recall number
- Z-2887-2026
In the FDA's words
- Description
- 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, 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. Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461 Distribution: U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN. Affected quantity: 43 units
- Hazard
- 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.