FDA-Device2017-01-25Class II
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
The Binding Site Group, Ltd.
Hazard
Batch numbers listed are reporting Lambda Free Light Chain results >114mg/L that are on average 33% lower than other Optilite Lambda Freelite batches. Therefore users moving to this batch will see results >114mg/L giving lower results and conversely when switching to the next batch results will be seen to shift upwards.
Sold states
U.S. distribution to the following; AR, PA, GA, NC, KY, VA, CA. Foreign distribution to the following; Uk, Germany, France, Italy, Spain, Czech Republic, Portugal, Belgium.
Affected count
809 kits
Manufactured in
8 Calthorpe Road, Birmingham, United Kingdom
Products
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1043-2017Don't want to check this manually?
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