Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Reported: January 25, 2017 Initiated: November 28, 2012 #Z-1050-2017
Product Description
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
Reason for Recall
Calibration curve activity has increased over time in the kit lots listed.
Details
- Recalling Firm
- The Binding Site Group, Ltd.
- Units Affected
- 1,002
- Distribution
- 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.
- Location
- Birmingham
Frequently Asked Questions
What product was recalled? ▼
Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.. Recalled by The Binding Site Group, Ltd.. Units affected: 1,002.
Why was this product recalled? ▼
Calibration curve activity has increased over time in the kit lots listed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1050-2017.
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