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HARDY DIAGNOSTICS · Model J65 · UDI-DI 00816576028108

KZI JSI

510(k) clearances

3,147

Adverse events

Recalls

Facilities

Description

Blood Agar 5% / CLED Agar with Bile, 15x100mm Biplate, 10ml/10ml. 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 CLED Agar is recommended for the isolation, enumeration, and presumptive identification of urinary pathogens on the basis of lactose fermentation, while controlling the swarming of Proteus spp.

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.