FDAFDA · Food and drugs·Recall number Z-1043-2017
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Published January 25, 2017 · Recall initiated: July 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Binding Site Group, Ltd.
- Distributor
- 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.
- Lot
- Lot #405566, 405567
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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