AnaeroGRO

HARDY DIAGNOSTICS · Model AG24H · UDI-DI 00819398020114

510(k) clearances

Adverse events

Recalls

Facilities

Description

Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Peptone Yeast Extract Glucose Broth (PYG) is an enriched, non-selective medium recommended for the cultivation and biochemical identification of obligately anaerobic microorganisms. This medium is also suitable for the growth of anaerobic bacteria to be identified by gas liquid chromatography (GLC) analysis as outlined by the CDC.

Recalls

Date	Firm	Reason
2021-09-30	bioMerieux, Inc.	There is potential to provide an incorrect organism identification.
2015-11-18	Hardy Diagnostics	The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fungorum contamination.
2012-12-10	Becton Dickinson & Co.	Enrichment media intended to enhance the cultivation of various microorganisms may fail to support the growth of Haemophilus species.
2012-02-20	Becton Dickinson & Co.	In vitro diagnostic reagent is defective and may fail to enhance the growth of microbiological cultures as intended.
2009-12-21	Remel, Inc	Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.

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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.