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HARDY DIAGNOSTICS · Model A20 · UDI-DI 00816576023974

KZI
10
510(k) clearances
3,143
Adverse events
2
Recalls
17
Facilities

Description

BHI Agar with Blood, 15x100mm Plate, 18ml. Hardy Diagnostics Brain Heart Infusion (BHI) Agar is a general purpose nutrient medium recommended for the cultivation and isolation of a variety of microorganisms, including bacteria, yeasts, and molds. The addition of defibrinated sheep blood and antimicrobics produces a selective medium used for the isolation of pathogenic fungi from specimens heavily contaminated with bacteria and saprophytic fungi.

Recalls

DateFirmReason
2009-02-19Becton Dickinson & Co.In vitro diagnostic test reagent may contain residual material that inhibits the growth of gram positive/gram negative organisms.
2004-09-27Remel, 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.