medical Class II Updated 2020-02-26

The Binding Site Group, Ltd. recalls OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, UT, IA

Lot/Code Info: Lot # 422251

View official government recall

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