Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.
FDA Recall Z-1050-2017 · Posted 2017-01-19
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Recalling FirmThe Binding Site Group, Ltd.
Recall StatusTerminated
Product CodeDEH
Date Initiated2012-11-28
Date Terminated2017-03-03
Product Quantity1,002
Reason for Recall
Calibration curve activity has increased over time in the kit lots listed.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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