FDA-Device2020-02-26Class II
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
The Binding Site Group, Ltd.
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.
Sold 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, WA, UT, IA,
Affected count
3294 kits
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1327-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief