HardyDisk™

HARDY DIAGNOSTICS · Model Z7025 · UDI-DI 00816576028306

510(k) clearances

Adverse events

Recalls

Facilities

Description

Bacitracin 0.04 units, HardyDisks™, for the differentiation of Group A Strep (Streptococcus pyogenes), 50 disks per cartridge, 5 cart., not for antimicrobial sensitivity tests, Used in the presumptive identification of group A, beta-hemolytic streptococci. The test differentiates group A streptococci from other Lancefield groups of hemolytic streptococci by inhibiting the growth of group A streptococci around a disk containing approximately 0.04 units bacitracin.

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.