Z-1043-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- July 5, 2016
- Termination Date
- July 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 809 kits
Product Description
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Lot #405566, 405567