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FDAFDA · Food and drugs·Recall number Z-1050-2017

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Published January 25, 2017 · Recall initiated: November 28, 2012

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

Calibration curve activity has increased over time in the kit lots listed.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
The Binding Site Group, Ltd.
Distributor
U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.
Lot
Lot #323278, 327963
Risk classification
Class II
Area (FDA)
device
Country
United Kingdom

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