FDA-Device2014-03-19Class II
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Biomerieux Inc
Hazard
The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result.
Sold states
Distribution was made to AK, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA and WI.
Affected count
471 instruments
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1177-2014Don't want to check this manually?
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