Meridian Bioscience Inc recalls PREMIER EHEC and PREMIER EHEC Bulk.
- Recall date
- November 8, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1033-2017
- FDA classification
- Class II
- Brand / firm
- Meridian Bioscience Inc
- Sold / distributed
- 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 ZEAL…
Why it was recalled
Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PREMIER EHEC and PREMIER EHEC Bulk.
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