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HARDY DIAGNOSTICS · Model W23 · UDI-DI 00816576027477

KZI

510(k) clearances

3,143

Adverse events

Recalls

Facilities

Description

Brucella Blood Agar with Hemin, and Vitamin K, 15x100mm plate, 26ml fill, order by the package of 10 (Brucella Agar with Hemin & Vitamin K) For the cultivation of anaerobes. A non-inhibitory general growth medium for all gram positive and gram negative anaerobic bacteria. Optimized formula for enhanced growth characteristics of anaerobes.

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.