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Recall Observatory FDA recall evidence

Device product

Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

Z-1053-2017

October 28, 2016

Class II

Product summary

Firm
The Binding Site Group, Ltd.
Event
Event 76050
Status
Terminated
Classification
Class II
Quantity
3,088
Official record key
device-enforcement:Z-1053-2017

Official wording

Reason: A change in the calibration curve causing an increase in false prozone flags.

Code information: Lot #400012, 400257

Distribution pattern: Worldwide Distribution - U.S. (nationwide) and Internationally to the following; Canada, Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A change in the calibration curve causing an increase in false prozone flags.