Medical device recalls Moderate risk

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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