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PRAS Peptone Yeast Extract Broth w/ Glucose & Formate/Fumarate FA/GLC

ANAEROBE SYSTEMS · Model AS-858 · UDI-DI 00810048901142

510(k) clearances

Adverse events

Recalls

Facilities

Description

AS-858 Peptone Yeast Extract Broth with Glucose and Formate/Fumarate FA/GLC (PYG FF FA/GLC) is designed for the determination of glucose fermentation and formate/fumarate stimulation by anaerobic bacteria for identification. PYG FF FA/GLC is recommended for use in identifying Campylobacter ureolyticus within the MIDI MIS procedures. Pre-reduced anaerobically sterilized (PRAS). 10 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent golden yellow liquid. 10 tubes per pack.

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.