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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