FDA-Device2012-10-17Class II
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Biomerieux Inc
Hazard
The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.
Sold states
Worldwide Distribution-USA (nationwide)-including DC and the states of CA, CO, CT, FL, GA, IL, IN, KY, LA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TX, and WI, and the country of Canada.
Affected count
350 systems
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2013Don't want to check this manually?
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