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Luminex Corporation recalls Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Recalled July 14, 2021 · FDA recall Z-2010-2021 · Luminex
Hazard
Potential for a false-negative result. · FDA Class II
Units
1,261
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 Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Manufacturer(s)
Luminex Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →