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PLEASE DELIVER UPON RECEIPT to LAB DIRECTOR or LAB MANAGER[to be date of distribution]Urgent Field Safety Noticer Ref: 4318 FSA Dear Valued bioMrieux Customer, Our records indicate that your laboratory
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The Biofire FilmArray Gastrointestinal (GI) panel is a molecular diagnostic test that allows for the rapid detection of various pathogens that cause gastrointestinal infections, including bacteria, viruses, and parasites.
Healthcare providers, laboratories, and facilities that perform gastrointestinal pathogen testing may be required to file reports related to the Biofire FilmArray GI results, depending on regulatory guidelines and local health department requirements.
Filling out the Biofire FilmArray GI involves following specific procedures outlined in the product's user manual, which include properly collecting, labeling, and processing the samples, then documenting the results in the appropriate reporting format.
The purpose of the Biofire FilmArray GI is to provide rapid and accurate identification of gastrointestinal pathogens to assist in diagnosing infections, guiding treatment decisions, and tracking outbreaks.
Information that must be reported typically includes patient demographics, sample collection details, test results, and any relevant clinical information that may impact patient care or epidemiological tracking.
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