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AnaeroGRO

HARDY DIAGNOSTICS · Model AG302 · UDI-DI 00816576024445

KZI JSJ JSI

510(k) clearances

3,143

Adverse events

Recalls

Facilities

Description

DuoPak A, BRU with Hemin and Vitamin K, Monoplate; BBE/LKV, Biplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.

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.