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The Binding Site Group, Ltd. recalls OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Recalled February 26, 2020 · FDA recall Z-1327-2020 · The Binding Site Group
Hazard
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. · FDA Class II
Units
3294 kits
Sold at
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,
Description
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.
Product
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Manufacturer(s)
The Binding Site Group, Ltd.
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →