HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with a high risk of harm because incorrect results could lead to ineffective antimicrobial therapy and worsening clinical outcomes, though no injuries have been reported.
Plain-English summary
Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (FDC30) REF Z9435, Lot Number 543461. This product is used for in vitro agar diffusion susceptibility testing to determine the susceptibility of various bacteria to Cefiderocol.
The recall was initiated because incorrect cartridges were included in the affected products. This error creates the potential for false-susceptible or false-resistant susceptibility results.
Inaccurate results may lead to the selection of ineffective antimicrobial therapy, which could potentially result in delayed appropriate treatment, prolonged infection, or worsening clinical outcomes.
This recall affects 43 units distributed nationwide in AZ, CA, FL, ID, IN, MA, MS, NJ, NV, NY, OH, PA, and TN.
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…
- Manufacturer
- Hardy Diagnostics
- Affected units
- 43
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: Z9435 UD-DI code: Pending Lot Number: 543461
Distribution
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