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Luminex Corporation recalls Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Recalled July 14, 2021 · FDA recall Z-2009-2021 · Luminex
Hazard
Potential for a false-negative result. · FDA Class II
Units
24,338
Sold at
Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
Description
Potential for a false-negative result.
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →