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Recall Observatory FDA recall evidence

Device product

Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

Z-1043-2017

July 05, 2016

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 76048
Status
Terminated
Classification
Class II
Quantity
809 kits
Official record key
device-enforcement:Z-1043-2017

Official wording

Reason: 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.

Code information: Lot #405566, 405567

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.