HardyDisk™

HARDY DIAGNOSTICS · Model Z9475 · UDI-DI 00819398021548

JTN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Rezafungin 5ug (RZF5), 5 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure(Kirby- Bauer) when there is the need to determine the susceptibility of microorganisms to Rezafungin. Product can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro: Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalist.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.