FDA-Device2017-01-25Class II
PREMIER EHEC and PREMIER EHEC Bulk.
Meridian Bioscience Inc
Hazard
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Sold states
Product was shipped to the following states: AL. AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WY. Product was also sent to the following countries: CANADA, GERMANY, HONG KONG, ITALY, JAPAN & NEW ZEALAND.
Affected count
4,747 EHEC + 180 EHEC Bulk
Manufactured in
3471 River Hills Dr, Cincinnati, OH, United States
Products
PREMIER EHEC and PREMIER EHEC Bulk.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2017Don't want to check this manually?
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