Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
This recall has been terminated (originally issued January 19, 2017).
- Company
- The Binding Site Group, Ltd.
- Recall Initiated
- November 28, 2012
- Posted
- January 19, 2017
- Terminated
- March 3, 2017
- Recall Number
- Z-1050-2017
- Quantity
- 1,002
- Firm Location
- Birmingham United Kingdom
- Official Source
- View on FDA website ↗
Reason for Recall
Calibration curve activity has increased over time in the kit lots listed.
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.
Lot / Code Info
Lot #323278, 327963
Root Cause
Unknown/Undetermined by firm
Action Taken
Customer notification letters were sent 11/28/12. Customers were asked to discontinue using the listed kit lots. Discard any unused or partially-used kits of these lots. Let The Binding Site know how many replacement kits are required.
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