United StatesHardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435, catalog number Z9435, lot number 543461 (43 units distributed nationwide in AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN; UD‑DI code pending) is affected. The recall was issued because incorrect cartridges were included in the affected products, which can produce false‑susceptible or false‑resistant susceptibility results and may lead to selection of ineffective antimicrobial therapy, delayed appropriate treatment, prolonged infection, or worsening clinical outcome.
What's being recalled
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,
Recalling firm: Hardy Diagnostics, Santa Maria, CA, United States.
How to identify it
Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)