HardyDisk™

HARDY DIAGNOSTICS · Model Z8321 · UDI-DI 00816576020522

JTN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Cefuroxime 30μg (CXM30) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

Recalls

Date	Firm	Reason
2026-06-08	Hardy Diagnostics	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
2024-12-23	Oxoid Limited	Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
2024-11-06	Becton Dickinson & Co.	BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months, may result in falsely r
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result
2024-01-08	Becton Dickinson & Co.	There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed result

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.