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HARDY DIAGNOSTICS · Model J71 · UDI-DI 00816576028061

KZI JSH JSI

510(k) clearances

3,147

Adverse events

Recalls

Facilities

Description

Urine Quad Plate (EMB/Modified XLD/Simmons Citrate/Blood Agar, 5%), 15x100mm Plate, 20ml. Hardy Diagnostics Blood Agar products are recommended for use as general purpose growth media for the isolation, cultivation, and differentiation of a wide variety of microorganisms. Hardy Diagnostics EMB Agar formulations are recommended for use as selective and differential media for the isolation of gram-negative bacilli (including coliform organisms and enteric pathogens) from clinical and nonclinical specimens. Hardy Diagnostics Simmons Citrate Agar is recommended for use in the differentiation of gram-negative enteric bacilli based on citrate utilization. Hardy Diagnostics XLD Agar with Novobiocin is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from foods or other samples. Modified XLD Agar is recommended for use as a selective and differential medium for the isolation of gram-negative enteric pathogens from specimens.

Recalls

Date	Firm	Reason
2009-02-19	Becton Dickinson & Co.	In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27	Remel, Inc.	The product does not perform as intended with some quality control organisms (Haemophilus influenzae)

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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.