FDA-Device2017-02-01Class III
Optilite IgG4 Kit Product Code: LK009.OPT.A
The Binding Site Group, Ltd.
Hazard
A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert
Sold states
U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
Affected count
9 users
Manufactured in
8 Calthorpe Road, N/A, Birmingham, N/A, United Kingdom
Products
Optilite IgG4 Kit Product Code: LK009.OPT.A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1089-2017Don't want to check this manually?
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