OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Reason: There is a potential that users may experience difficulty validating the calibration of the kit. This is indicated by kit control values reporting outside the specified ranges. This could result in potential false patient results which could cause a delay until repeat testing is performed.

Code information: Lot # 422251

Distribution pattern: CA, PA, FL, AR, SD, MA, WV, AL, GA, IL, MN, MD, AZ, NC, TN, WA, MI, NY, KY, SC, IN, OR, NE, OH, TX, VT, WA, UT, IA,